(90 days)
There are several items that make up this system. They will be listed separately with their intended use:
Cable Implants:
Femur and Tibial Fractures Prophylactic banding Trochanteric reattachment Olecranon fractures Patella fractures Ankle fractures Fixation of spiral fractures in conjunction with I/M nailing and screwing techniques. Sternum fixation after open chest surgery Stabilization of cortical onlay strut graft Trochanteric Grip: Reattachment of greater trochanter following osteomy for total hip or total hip Procedures or trochanteric advancement
Cable Plates
Fixation of femoral, tibial or humeral fractures near the site of an intramedullary implant
Fixation of fractures where a combination of screws and cerclage cables would improve stabilization
Supracondylar Cable Plate
Distal femoral fractures
Subtrochanteric fractures
Lateral Trochanteric Plate
Extended trochanteric osteomies
Trochanteric fractures
The BMP™ Cable System consists of cables, cable sleeves, trochanteric grip, cable plates and cable templates. The system also includes lateral trochanteric plates and supercondylar plates. The cables and cable sleeves are made of either cobalt chrome or stainless steel. All cables are 7x7 construction. Seven individual wires form a bundle and seven bundles are combined to form each cable optimizing strength and flexibility. The cobalt chrome is available in 2.0mm and 1.6mm diameter cables to be used with titanium and cobalt chrome implants. The stainless steel cables are 2.0mm diameter and used with stainless steel implant and the BMP cable plates. Three sleeves are available: 2.0mm CoCr. 1.6mm CoCr and 2.0mm stainless steel.
The trochanteric grips are cobalt chrome and are available in two sizes – medium and large. Each grip has two crimp locations and do not require additional sleeves. The holes on the tronchateric grip are full radius.
The cable plates are available in five lengths from 110mm to 310mm. Each plate is a one piece plate and sleeve construction manufactures from 316 LVM stainless steel. The one-piece construction allows for the sleeves to be machined directly on each plate, thus eliminating micromotion between the plate and sleeves. Stainless steel cable and screws are used to attach these plates to bone. The system includes templates for the corresponding plate size. A smaller plate for use on the humerous is being planned.
There are two specialty plates in the system. The supracondylar cable plate comes in two lengths, 165 mm and 241 mm. The plate is manufactured out of 316 LVM stainless steel. Stainless steel screws and cables are used to attach this plate to bone. The lateral trochanteric plate is a Co-Cr-Mo plate that is manufactured in one length -185 mm. It is attached to the bone with titanium screws and Co-Cr- Mo cable.
Instruments for use with these devices include cable passers, crimper, standard trochanteric grip impactor, T- handle tensioner, cable cutters, trochanteric grip manipulator/impactor and sterilization case.
The provided text is a 510(k) premarket notification for the BMP™ Cable System, an orthopedic metallic internal fixation device. This type of submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and extensive performance studies as one might find for novel or high-risk devices.
Therefore, the document does not contain the typical acceptance criteria and study details requested for a device performance study. Instead, it relies on the established safety and effectiveness of its predicate devices.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. The document does not define specific performance acceptance criteria (e.g., tensile strength, fatigue life thresholds) or report device performance against such criteria. The basis for equivalence is the similarity in design, materials, and intended use to predicate devices already on the market.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. No explicit "test set" or associated data provenance (country of origin, retrospective/prospective) and sample size are mentioned in the context of a performance study proving criteria. The submission relies on the established performance of predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. There is no mention of experts establishing ground truth for a test set, as this is not a clinical study designed to test the diagnostic or predictive accuracy of a device.
4. Adjudication Method for the Test Set:
- Not Applicable. No adjudication method is described as there is no performance study with a test set requiring ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is not mentioned. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI assistance. The BMP™ Cable System is a surgical implant.
6. Standalone (Algorithm Only) Performance Study:
- No. No standalone performance study is mentioned. This concept is applicable to AI algorithms. The BMP™ Cable System is a physical medical device.
7. Type of Ground Truth Used:
- Not Applicable. The concept of "ground truth" (e.g., pathology, outcomes data) as it applies to performance evaluation in diagnostic/predictive devices is not relevant to this submission. The "ground truth" for this device's approval is its substantial equivalence to already approved, safe, and effective devices based on design and intended use.
8. Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of this device, as it is a physical implant and not an AI algorithm requiring training.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set, there is no ground truth establishment for it.
Summary based on the 510(k) document:
The provided document describes a 510(k) premarket notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process does not typically involve extensive clinical performance studies with acceptance criteria like those for novel devices or AI/diagnostic tools.
The "study" in this context is the comparison to predicate devices already on the market. The criteria for acceptance are based on demonstrating:
- Similar intended use: The BMP™ Cable System is indicated for general orthopedic repairs, similar to its predicates.
- Similar technological characteristics: The system consists of cables, sleeves, grips, and plates made of materials like cobalt chrome and stainless steel, with similar constructions (e.g., 7x7 cable construction) to predicate devices.
- Similar potential risks: The document lists potential risks that are common to all cerclage systems, implying no new or increased risks compared to predicates.
The FDA's letter (K982545) confirms that they reviewed the submission and determined the device to be substantially equivalent to predicate devices. This determination is the "proof" that the device meets the regulatory acceptance criteria for market authorization based on the 510(k) pathway.
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K982545
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SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR: Biomet, Inc. Airport Industrial Park Warsaw, Indiana 46580
Contact Person: Julie K. Ryan
PROPIETARY NAME: BMP™ Cable System
COMMON OR USUAL NAME: Metallic Internal Fixation Devices Cerclage Cable System
CLASSIFICATION NAME: Bone, fixation Cerclage 888.3010 Plate, Fixation, Bone 888.3030
DEVICE CLASSIFICATION: Class II
DEVICE PRODUCT CODE: 87 JDQ
INTENDED USE: The BMP™ Cable System is indicated for general orthopedic repairs. This includes such procedures as long bone fractures, bone grafting, reinforcement of bone and reattachment of the greater trochanter.
DESCRIPTION OF DEVICE: The BMP™ Cable System consists of cables, cable sleeves, trochanteric grip, cable plates and cable templates. The system also includes lateral trochanteric plates and supercondylar plates. The cables and cable sleeves are made of either cobalt chrome or stainless steel. All cables are 7x7 construction. Seven individual wires form a bundle and seven bundles are combined to form each cable optimizing strength and flexibility. The cobalt chrome is available in 2.0mm and 1.6mm diameter cables to be used with titanium and cobalt chrome implants. The stainless steel cables are 2.0mm diameter and used with stainless steel implant and the BMP cable plates. Three sleeves are available: 2.0mm CoCr. 1.6mm CoCr and 2.0mm stainless steel.
The trochanteric grips are cobalt chrome and are available in two sizes – medium and large. Each grip has two crimp locations and do not require additional sleeves. The holes on the tronchateric grip are full radius.
The cable plates are available in five lengths from 110mm to 310mm. Each plate is a one piece plate and sleeve construction manufactures from 316 LVM stainless steel. The one-piece construction allows for the sleeves to be machined directly on each plate, thus eliminating micromotion between the plate and sleeves. Stainless steel cable and screws are used to attach these plates to bone. The system includes templates for the corresponding plate size. A smaller plate for use on the humerous is being planned.
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K982545
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There are two specialty plates in the system. The supracondylar cable plate comes in two lengths, 165 mm and 241 mm. The plate is manufactured out of 316 LVM stainless steel. Stainless steel screws and cables are used to attach this plate to bone. The lateral trochanteric plate is a Co-Cr-Mo plate that is manufactured in one length -185 mm. It is attached to the bone with titanium screws and Co-Cr- Mo cable.
Instruments for use with these devices include cable passers, crimper, standard trochanteric grip impactor, T- handle tensioner, cable cutters, trochanteric grip manipulator/impactor and sterilization case.
POTENTIAL RISKS: The potential risks associated with this device are the same as with any other clerclage system. These include but not limited to:
Nonunion or delayed union Bending or fracture of the implant Metal sensitivity or allergic reaction to foreign body Limb shortening due to compression of fracture bone Bone resorption Decrease in bone density due to stress shielding Pain, discomfort, or abnormal sensations due to the presence of the device Nerve damage due to surgical trauma Necrosis of bone
SUBSTANTIAL EQUIVALENCE: The BMP™ Cable System is substantially equivalent to most cable/Cerclage system on the market in overall design and intended function.
Predicate devices include:
Dall-Miles Cable System by Howmedica (K971741) Dall-Miles Trochanter Cable Grip System by Howmedica (K934058) Osteo-Clage Cable System by Acumed, Inc. (K921480) J-Fx Cerclage System by Johnson and Johnson (K971682) Epi-Union Plating System by Howmedica (K974289) Osteo-Anatomical bone Plates by Oestonics Corp.(K972196)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or lines extending from the head, resembling a bird in flight. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 19 1998
Ms. Julie K. Ryan Requlatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
Re: K982545 BMP™ Cable System Trade Name: Regulatory Class: II Product Codes: JDQ and HRS Dated: July 17, 1998 Received: July 21, 1998
Dear Ms. Ryan:
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 The general controls provisions of the Act 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 regulation 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 - Ms. Julie K. Ryan
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,
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
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510 (K) NUMBER IF KNOWN: DEVICE NAME: BMP CABLE SYSTEM
Indications of Use:
There are several items that make up this system. They will be listed separately with their intended use:
Cable Implants:
Femur and Tibial Fractures Prophylactic banding Trochanteric reattachment Olecranon fractures Patella fractures Ankle fractures Fixation of spiral fractures in conjunction with I/M nailing and screwing techniques. Sternum fixation after open chest surgery Stabilization of cortical onlay strut graft Trochanteric Grip: Reattachment of greater trochanter following osteomy for total hip or total hip Procedures or trochanteric advancement
Cable Plates
Fixation of femoral, tibial or humeral fractures near the site of an intramedullary implant
Fixation of fractures where a combination of screws and cerclage cables would improve stabilization
Supracondylar Cable Plate
Distal femoral fractures
Subtrochanteric fractures
Lateral Trochanteric Plate
Extended trochanteric osteomies
Trochanteric fractures
(PLEASE DO NOT WRITE BELOW THEIS LINE-CONTINUE ON ANOTHER PAGE (IF NENDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
or
Over-the-CounterUse (Optional Format 1-2-96)
t
(Divide Sign Off)
neral Res 510(k) Number
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§ 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.