(240 days)
No
The summary describes a mechanical bone plate and screw system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as actively providing continuous compression across a fusion site for fracture treatment, which directly serves a therapeutic purpose.
No
The device, "BME Converge™", is described as a bone plate and screw system for fixing bone fractures, which is an therapeutic function, not diagnostic.
No
The device description clearly states that the device consists of a sterile bone plate and sterile titanium screws, which are physical hardware components.
Based on the provided text, the Converge™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is indicated for the treatment of bone fractures. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a bone plate and screws designed to provide compression across a fracture site. This is a mechanical device used for surgical fixation.
- Lack of IVD Characteristics: The text does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition or disease.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Converge™ device is used in vivo (inside the body) for surgical treatment.
N/A
Intended Use / Indications for Use
The Converge™ is indicated for fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulna, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The BME Converge™ consists of a sterile bone plate offered in various configurations and sterile titanium screws. The Converge™ is situated on two bones, across the fracture site, with titanium locking screws extending through the plate and cortex. The Converge™ is activated at room temperature upon release from retention brackets. In its final configuration, the plate actively provides continuous compression across the fusion site.
The Converge™ system contains plates and screws in similar shapes and sizes and manufactured from the same materials according to the same steps as the reference device, Nitinol Compression Plating System™ (NCP). However, the Converge™ includes the addition of K-wire and retention brackets (as opposed to NCP's restraining instrument). The configurations of the BME Converge™ system include Straight shaped implants. Additionally, the BME Converge has been MR tested and results indicate it is MR Conditional, whereas the BME Nitinol Compression Plating System has not undergone MR testing.
The main differences between the BME Converge™ and the primary predicate, GPC Medical Bone Plates and Bone Screws include the configurations and the material. The GPC Medical Bone Plates are made out of titanium whereas the BME Converge plates are made out of nitinol. The GPC Medical Bone Plate system is either a rectangular or "T" shaped implant with four to seven holes for screws, while the Converge plate system includes a straight shape. Additionally, results of MR testing conclude that BME's Converge™ may be listed as MR Conditional. It is unclear whether GPC Medical bone Fixation Plates and Screw System have undergone MR testing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, pelvis, scapula, long bones (humerus, radius, ulna, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.
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)
BME conducted a series of tests to compare the submitted devices to the predicates. The testing included: Static bend, Dynamic bend, Post fatigue corrosion, Post fatigue nickel leaching, Corrosion, Galvanic corrosion, MRI compatibility, MRI RF heating simulation, Bone screw insertion and removal, Plate compression, Bone screw torsion, Bone screw pull-out and Bone screw corrosion resistance. The results demonstrate substantial equivalence to predicate device.
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.
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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2016
BioMedical Enterprises, Incorporated Mr. Joe Soward Director, Quality Assurance and Regulatory Affairs 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245
Re: K153573 Trade/Device Name: Coverge™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: July 8, 2016 Received: July 11, 2016
Dear Mr. Soward:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Vincent J. Devlin -S
for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153573
Device Name Converge™
Indications for Use (Describe)
The Converge™ is indicated for fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulna, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for BioMedical Enterprises. The logo consists of a stylized, gray-colored design that resembles a series of interconnected staples or fasteners. Below the graphic is the text "BioMedical Enterprises" in an orange sans-serif font.
510(K) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the Converge™.
| 1. Submitted By: | BioMedical Enterprises, Inc.
14785 Omicron Dr., Suite 205
San Antonio, TX 78245 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Date: | August 9, 2016 |
| Contact Person: | Joe Soward
Director Quality Compliance and
Regulatory Affairs
Office: 210-881-0011
Fax: 210-677-0355 |
| | Gretchen Upton
Regulatory Affairs Specialist
Office: 210-881-0043
Fax: 210-677-0355 |
| 2. Proprietary Name: | Converge™ |
| Common Name: | Bone Plate and Screws |
| Classification Name and Definition: | 21 CFR 888.3030 – Single/multiple
component metallic bone fixation appliances
and accessories. |
| | 21 CFR 888.3040 – Smooth or threaded
metallic bone fixation fastener. |
| Device Product Code, Device Panel: | HRS – Orthopedic Devices |
| | HWC – Orthopedic Devices |
| 3. Primary Predicate: | GPC Medical Bone Plates and Bone Screws
K092493 |
| Reference Device: | Nitinol Compression Plating System™
K143023 |
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Image /page/4/Picture/0 description: The image shows the logo for BioMedical Enterprises. The logo consists of a stylized gray image of three staples. Below the image is the text "BioMedical Enterprises" in an orange sans-serif font.
4. Device Description:
The BME Converge™ consists of a sterile bone plate offered in various configurations and sterile titanium screws. The Converge™ is situated on two bones, across the fracture site, with titanium locking screws extending through the plate and cortex. The Converge™ is activated at room temperature upon release from retention brackets. In its final configuration, the plate actively provides continuous compression across the fusion site.
The Converge™ system contains plates and screws in similar shapes and sizes and manufactured from the same materials according to the same steps as the reference device, Nitinol Compression Plating System™ (NCP). However, the Converge™ includes the addition of K-wire and retention brackets (as opposed to NCP's restraining instrument). The configurations of the BME Converge™ system include Straight shaped implants. Additionally, the BME Converge has been MR tested and results indicate it is MR Conditional, whereas the BME Nitinol Compression Plating System has not undergone MR testing.
The main differences between the BME Converge™ and the primary predicate, GPC Medical Bone Plates and Bone Screws include the configurations and the material. The GPC Medical Bone Plates are made out of titanium whereas the BME Converge plates are made out of nitinol. The GPC Medical Bone Plate system is either a rectangular or "T" shaped implant with four to seven holes for screws, while the Converge plate system includes a straight shape. Additionally, results of MR testing conclude that BME's Converge™ may be listed as MR Conditional. It is unclear whether GPC Medical bone Fixation Plates and Screw System have undergone MR testing.
5. Intended Use
The Converge™ is indicated for fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulna, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.
6. Technological Characteristics Comparison
The Converge™ Nitinol Compression Plate system and primary predicate GPC Medical Bone Plate system share the same technological characteristics. More specifically, they share the same indications and intended use. The primary differences between the devices involve differences in geometry related to plate configuration and plate thickness, delivery method, and implant material, in that the Converge™ plate is made of nitinol and the GPC plate is made of titanium.
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Image /page/5/Picture/0 description: The image shows the logo for BioMedical Enterprises. The logo consists of a stylized, gray-colored design that resembles a series of interconnected staples or fasteners, each with pointed ends. Below the design, the words "BioMedical Enterprises" are written in an orange sans-serif font.
7. Substantial Equivalence - Non-Clinical Evidence
The Converge™ is substantially equivalent to primary predicate GPC Medical Bone Plates and Bone Screws cleared in K092493. That clearance also included the DHS/DCS Plate System, the designs and indications of which we do not claim substantial equivalence. In addition, the BME Converge™ is manufactured from the same materials using the same processes as FDA cleared reference device BME Nitinol Compression Plating System™ K143023.
BME conducted a series of tests to compare the submitted devices to the predicates. The testing included: Static bend, Dynamic bend, Post fatigue corrosion, Post fatigue nickel leaching, Corrosion, Galvanic corrosion, MRI compatibility, MRI RF heating simulation, Bone screw insertion and removal, Plate compression, Bone screw torsion, Bone screw pull-out and Bone screw corrosion resistance. The results demonstrate substantial equivalence to predicate device.
8. Substantial Equivalence - Clinical Evidence
Not Applicable
- Substantial Equivalence - Conclusions
The design characteristics of the subject devices do not raise any new types of questions regarding safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate system and are substantially equivalent.