(169 days)
Not Found
No
The device description and intended use focus on the mechanical properties and surgical applications of a cable system made of titanium or stainless steel. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The performance studies are non-clinical and focus on functional equivalence, not algorithmic performance.
No.
The device is a cable system used for reattachment and wiring in various surgical applications, primarily providing mechanical support rather than directly treating a disease or condition. It is an implantable medical device designed to secure and stabilize structures.
No
The provided text describes the Biomet® Cable System as a surgical implant used for securing bones and other implants, not for diagnosing medical conditions.
No
The device description explicitly states the system consists of physical components made of titanium or stainless steel (cable, crimp, instruments like tensioner, crimper, and cutter). This is a hardware-based medical device.
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, tissue) to provide information about a person's health. This testing is done outside of the body.
- Biomet® Cable System Function: The description clearly states that the Biomet® Cable System is an implantable device used for surgical procedures to secure bones and other implants within the body. It is used in vivo (within the living body).
- Intended Use: The intended use describes surgical applications for spinal, hip, sternum, and trauma surgeries. This is a direct surgical intervention, not a diagnostic test performed on a specimen.
- Device Description: The device is a cable system made of titanium or stainless steel, designed to be implanted and secured with crimps. This is a surgical implant, not a diagnostic instrument or reagent.
The information provided about the device's intended use, device description, and lack of any mention of analyzing biological specimens confirms that it is a surgical implant and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Biomet® Cable System is indicated for use whenever a conservative or non-implant surgery is deemed insufficient to improve the medical condition of the patient. The System can be utilized anywhere monofilament wire has been previously indicated.
-
- Spinal applications include spinal degenerative surgery, as an adjunct to spinal fusions and sublaminar and intraspinous process wiring for trauma applications. The Biomet® Cable System may also be used with instrumentation involving the correction of scoliotic, kyphotic, and lordotic deformities. The titanium system is compatible with other titanium implants and the stainless steel system with stainless steel implants, wherever "wiring" may help secure the attachment of other implants.
-
- Trochanteric reattachment after trochanteric osteotomy, following total hip arthroplasty.
-
- Sternotomy indications include the "re-wiring" of sternums following osteotomy.
-
- Trauma surgery indications include olecranon, ankle, patella, and some shoulder fracture rewiring.
Product codes (comma separated list FDA assigned to the subject device)
JDQ
Device Description
The Biomet® Cable System is available in either titanium or stainless steel, consisting of a flexible, multi-strand, medical grade titanium alloy (Ti-6Al-4V, ASTM F-136) or a medical grade stainless steel (316LVM, ASTM F-138) cable. The systems are available in both single and double styles. The cable is locked into place via a pre-loaded crimp. Instruments for the Biomet® Cable System include a Cable Tensioner, a Cable Crimper, and a Cable Cutter. The titanium system is compatible with other medical grade implants made of titanium and the stainless steel system is compatible with other stainless steel implants, whenever "wiring" may help secure the attachment of other implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, Trochanteric, Sternum, Olecranon, Ankle, Patella, Shoulder
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 determine substantial equivalence. The results indicated that the device was functional within its 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.
K920201, K925812, K030816, K922952
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
OCT 2 3 2007
510(k) Summary
| Preparation Date: | October 17, 2007 |
|---|---|
| Applicant/Sponsor: | Biomet Spine (aka EBI, names may be used interchangeably) |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Contact Person: | Becky Earl/Debra L. Bing |
| Proprietary Name: | Biomet® Cable System |
| Common Name: | Cable System |
| Classification Name: | Cerclage, Bone Fixation (CFR 888.3010) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Medtronic/Sofamor Danek Atlas™ Cable System, K920201, K925812, K030816; Songer Spinal Cable System, K922952.
Device Description: The Biomet® Cable System is available in either titanium or stainless steel, consisting of a flexible, multi-strand, medical grade titanium alloy (Ti-6Al-4V, ASTM F-136) or a medical grade stainless steel (316LVM, ASTM F-138) cable. The systems are available in both single and double styles. The cable is locked into place via a pre-loaded crimp. Instruments for the Biomet® Cable System include a Cable Tensioner, a Cable Crimper, and a Cable Cutter. The titanium system is compatible with other medical grade implants made of titanium and the stainless steel system is compatible with other stainless steel implants, whenever "wiring" may help secure the attachment of other implants.
Indications for Use: The Biomet® Cable System is indicated for use whenever a conservative or nonimplant surgery is deemed insufficient to improve the medical condition of the patient. The System can be utilized anywhere monofilament wire has been previously indicated.
-
- Spinal applications include spinal degenerative surgery, as an adjunct to spinal fusions and sublaminar and intraspinous process wiring for trauma applications. The Biomet® Cable System may also be used with instrumentation involving the correction of scoliotic, kyphotic, and lordotic deformities. The titanium system is compatible with other titanium implants and the stainless steel system with stainless steel implants, wherever "wiring" may help secure the attachment of other implants.
-
- Trochanteric reattachment after trochanteric osteotomy, following total hip arthroplasty.
-
- Sternotomy indications include the "re-wiring" of sternums following osteotomy.
-
- Trauma surgery indications include olecranon, ankle, patella, and some shoulder fracture rewiring.
Summary of Technologies:
The technological characteristics (materials, design, sizing, indications) of the Biomet® Cable System are similar or identical to the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc., except for Atlas™, which belongs to Medtronic/Sofamor Danek
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Image /page/1/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 symbol that resembles a human figure or a caduceus, with three wavy lines representing the body and a stylized head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2007
Biomet Manufacturing Corp % Ms. Becky Earl Regulatory Specialist P. O. Box 587 Warsaw, IN 46581
Re: K071271
Trade/Device Name: Biomet® Cable Ssystem Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: October 17, 2007 Received: October 18, 2007
Dear Ms. Earl:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Ms. Becky Earl
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): ______________
Device Name: Biomet® Cable System
Indications for Use: The Biomet® Cable System is indicated for use whenever a conservative or non-implant surgery is deemed insufficient to improve the medical condition of the patient. The System can be utilized anywhere monofilament wire has been previously indicated.
-
- Spinal applications include spinal degenerative surgery, as an adjunct to spinal fusions and sublaminar and intraspinous process wiring for trauma applications. The Biomet® Cable System may also be used with instrumentation involving the correction of scoliotic, kyphotic, and lordotic deformities. The titanium system is compatible with other titanium implants and the stainless steel system with stainless steel implants, wherever "wiring" may help secure the attachment of other implants.
-
- Trochanteric reattachment after trochanteric osteotomy, following total hip arthroplasty.
-
- Sternotomy indications include the "re-wiring" of sternums following osteotomy.
-
- Trauma surgery indications include olecranon, ankle, patella, and some shoulder fracture rewiring.
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)
[signature]
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K07127
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