(117 days)
Not Found
No
The device description and performance studies focus on mechanical fixation and comparison to traditional sutures and wires, with no mention of AI or ML technologies.
Yes
The device is intended for stabilization and fixation of fractures, which are therapeutic actions to restore normal function or heal an injury.
No
The device is described as a system for stabilizing and fixing fractures of the anterior chest wall. Its purpose is to aid in alignment and stabilization of bone after surgical procedures, not to identify or diagnose a medical condition.
No
The device description explicitly mentions "Implants for this application include Clips and ZipLoop™ constructs packaged with single use instruments to assist in insertion and applying tension". This indicates the device is a physical implant and associated instruments, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The Biomet Sports Medicine Sternal Closure System is described as being used for the "stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures." This involves physically implanting devices within the body to support bone.
- Intended Use: The intended use clearly states it's for surgical procedures involving the sternum, which is an in-vivo (within the body) application.
The information provided describes a surgical implant system, not a device used for laboratory testing of bodily specimens.
N/A
Intended Use / Indications for Use
The Biomet Sports Medicine Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
JDQ
Device Description
The Biomet Sternal Fixation Devices System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. The Implants for this application include Clips and ZipLoop™ constructs packaged with single use instruments to assist in insertion and applying tension to close the ZipLoop™ construct to the desired size. The Biomet Sternal Fixation System Devices are single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chest wall (sternal)
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)
Non-Clinical Testing: Non-clinical laboratory testing was performed to verify the fixation strength of the Biomet Sports Medicine Sternal Closure System in cyclic fatigue testing as compared to the predicate devices for specific indications for use. The efficacy of the Biomet Sports Medicine Sternal Closure System was compared to that of the Ethicon Surgical Stainless Steel Sutures. The test results indicate that the Biomet Sports Medicine Sternal Closure System provide equivalent cyclic fatigue strength to the predicate devices and would be functional within their intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K931271, K946173, K930015, K013059, K011076, K063506
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K 110039 (pg. 1 of 2)
Image /page/0/Picture/1 description: The image shows the logo for Biomet Sports Medicine. The logo consists of the word "BIOMET" in a stylized font, with the letters connected and enclosed in a rectangular border. Below the word "BIOMET" is the phrase "SPORTS MEDICINE" in a simple, sans-serif font. The logo is black and white.
MAY - 3 2011
510(k) Summarv
| Preparation Date: | April 13, 2011 |
|---|---|
| Applicant/Sponsor: | Biomet Sports Medicine |
| Contact Person: | Elizabeth Wray / Regulatory Project Manager |
| Victor Rodgers / Director of Quality, Clinical, & Regulatory | |
| Affairs | |
| (574) 267-6639 | |
| Proprietary Name: | Biomet Sports Medicine Sternal Closure System |
| Common Name: | Sternal Closure System |
| Classification Name: | Cerclage, Fixation (21CFR §888.3010) JDQ |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| K931271 and K946173 | Ethi-Pack Surgical Stainless Steel Suture |
|---|---|
| K930015 and K013059 | Stony Brook Sterna-wire / Sterna-Band™ |
| K011076 and K063506 | SternaLock™ Rigid Sternal System / Lorenz Sternal Closure System |
Device Description:
The Biomet Sternal Fixation Devices System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. The Implants for this application include Clips and ZipLoop™ constructs packaged with single use instruments to assist in insertion and applying tension to close the ZipLoop™ construct to the desired size. The Biomet Sternal Fixation System Devices are single use.
Intended Use:
The Biomet Sports Medicine Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
Summary of Technologies:
The technological characteristics (materials, design, sizing and indications) of the Biomet Sports Medicine Sternal Closure System are similar or identical to the predicate devices or
Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.267.6639
Main Fax: 574.267.8137
www.biomet.com
Shipping Address:
16 East Bell Drive
Warsaw, IN 46582
1
K110039 (pg. 2 of 2)
other previously cleared devices.
Non-Clinical Testing:
Non-clinical laboratory testing was performed to verify the fixation strength of the Biomet Sports Medicine Sternal Closure System in cyclic fatigue testing as compared to the predicate devices for specific indications for use. The efficacy of the Biomet Sports Medicine Sternal Closure System was compared to that of the Ethicon Surgical Stainless Steel Sutures. The test results indicate that the Biomet Sports Medicine Sternal Closure System provide equivalent cyclic fatigue strength to the predicate devices and would be functional within their intended use.
Clinical Testing:
None provided as a basis for substantial equivalence. .
All trademarks are the property of Biomet, Inc., except for Stema-Band™ which is a registered trademark of Peninsula Medical Products, LLC
DCC
5/4/11
2
Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like design with three curved lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-00022
Biomet Sports Medicine % Ms. Elizabeth Wray Regulatory Project Manager 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46587
MAY - 3 2011
Re: K110039
Trade/Device Name: Biomet Sports Medicine Sternal Closure System
Regulation Number: 21 CFR 888 2020 Regulation Number: 21 CFR 888.3020 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: April 13, 2011 Received: April 14, 2011
Dear Ms. Wray: -
We have reviewed your Section 510(k) premarket notification of intent to market the device is a refered above and have determined the device is substantially equivalent to market the device
refered above and have determined the device is substantially equivalent for the for use and in the enclosure) to legally marketed predicate devices market in the terest.
Tor use stated in the enclosure) to legally marketed in interstate comments in election in tegally marketed predicate devices marketed in intersations
devices in to May 28, 1976, the enactment date of the Medical marketed in interstate
and C device in they 26, 1970, the enactment date of the Medical Incontributions of the State
devices hat have been reclassified in accordance with the provisions of the Federal Fo and Committere occh recure approval of a provisions of the Provisions of to
and Cometic Act (Act) that do not require approval of a premarket a of Drug. On Drug.
Comments of You may, the (rec) that do not require approval of a prematket approval province (reg.
You may, the the device, subject to the general controls provisions of the Act. The general controls market the Act include requirements for annual registsons of the Arthur (Pho
general controls provisions of the Act include requirements for annual registrat of the world provisions of the Act include requirements for annual registration is increases
devices, good manufacturing practice, labeling, and prohibitions against mistrand adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
four de subject to additional controls. Existing major regulations of may be subject to addition (see above) into either class II (Special Controls) or class III (PMA)
found in to additional controls. Existing major regulations affecting your found in the Code of Federal Regulations, Title 21, Parts 800 to 800 in (1 Miles in (1 Miles)
found in the Code of Federal Regulations, Title 21, Parts 800 to 800 m (1 min 1 the 2001 - 1 Cuclar Regulations, Title 21, Parts 800 to 898. In addition
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
the say Felect that France and TDA s Issuance of a substantial squivalence detemination dos not mean
that Floral statutes and regulations administered by other requirements of the Act of any with thias a decemmation that your devices with other manon about on the more and completed by and reguirements, including, but not limited to: register. You music of the Ace
CFR Part 807), labeling (21 CFR Part 801), but not limited to: registration and l CFR Part 807); abeling (21 CFR Part 801); medical device reporting (reporting (reporting (reporting (reporting (reporting (reporting (reporting (reporting of medical device and are events) (21 CFR 801); medical device reporting (good monded and disculg (2)
cortice related adverse events) (21 CFR 803); good manufacturing practice requirem forth in the quality systems (QS) regulation (2) CFR Part Corner of nactical (2010)
forth in the quality systems (QS) regulation (21 CFR Part 820); and ractive the electronic the has product radiation of stems (QS) regulation (21 CFR Part 820), and if applicable, the are a
product radiation control provisions (Sections 531-542 of the Act); 21 CFR
3
Page 2 - Ms. Elizabeth Wray
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
the Center for Brotin Box/AboutFDA/CentersOffices/CDRH/CDRHC/S and Poster openite advice tor your device on our labeling regulation (21 CFR Part 801), please
the Center for Devices and Radiological Health's (CDRH)Offices/CDRH/Offices/C the Continues and Radiological Health's (CDRHO) CDRHOffices/Cm (CDRHOff.)
not Center for Devices and Radiological Health's (CDRHO Compliance, Also, please 11300 100 Dorices and Raublogical Health's (CDRH's) Office of Compliance. Also, ph to
807.7). For questions by reference to premarket nocomarket nocompliance. Also, planet on and organation comments by reference to premarkets of million" (216). Por questions (216).
CFR Part 803), please go to
10 100 1000), prese go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.brundor the CDRH's Office - Surveillance and Biometrics/Devices/Safety/ReportaProblem/default.
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 the Act from the
(80) 638-2041 or (301) 796-7100 or at its International and Consumer Assistance at its (800) 638-2041 or (301) 796-7100 or at its Internet address 1964) 1982 2017 of (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.html.
.ResourceCstor.You/industry/default.htm.
Sincerely yours.
Aliz B. Rita
for
Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K | 0039
Device Name: Biomet Sports Medicine Sternal Closure System
Indications For Use:
The Biomet Sports Medicine Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Asr M. Melkersson
Page 1 of 1
(Division Sigh Off) (Division of Surgical, Orthopedic, Division of Surges
Number K110039
510(k) Number .