(125 days)
Not Found
No
The summary describes a bone cement and its physical properties and performance testing, with no mention of AI or ML.
Yes
The device is used for the fixation of pathological fractures to alleviate pain, which is a therapeutic purpose.
No
The device description clearly states it is a "high-viscosity, radiopaque, self-curing, PMMA bone cement" used for fixation of pathological fractures, which indicates it is a therapeutic or restorative device, not a diagnostic one.
No
The device is a bone cement, which is a physical material used in surgical procedures, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of pathological fractures of the vertebral body using surgical procedures (vertebroplasty or kyphoplasty). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a bone cement, a material used for structural support within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
Therefore, the CONCORD Plus™ Radiopaque Bone Cement is a medical device used in a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CONCORD Plus™ Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Product codes (comma separated list FDA assigned to the subject device)
NDN
Device Description
The CONCORD Plus™ Radiopaque Bone Cement is a high-viscosity, radiopaque, self-curing, PMMA bone cement. It is provided sterile, as a two component system, a liquid component and a powder component which are mixed together prior to use to form the cement. The bone cement is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebral body
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)
Performance data was conducted in accordance with the Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement, July 17, 2002. Performance data demonstrates substantial equivalence to the predicate. Performance testing, chemical testing and handling properties were conducted to characterize CONCORD Plus™ Radiopaque Bone Cement compared to the predicate in compliance with ASTM D732-10, ASTM D5045-14, ASTM F2118-14, ASTM D638-10, ASTM F451-08, ASTM D2990-09, and ISO 5833:2002.
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.
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
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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 text "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
January 23, 2017
Globus Medical, Inc. Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K162618
Trade/Device Name: CONCORD Plus"11 Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: December 8, 2016 Received: December 9, 2016
Dear Dr. Baker:
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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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Page 2 - Kelly J. Baker, Ph.D.
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" (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 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.
Mark N. Melkerson -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162618
Device Name CONCORD Plus™ Radiopaque Bone Cement
Indications for Use (Describe)
CONCORD Plus™ Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
| 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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510(k) Summary CONCORD Plus Radiopaque Bone Cement
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D.
Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | December 8, 2016 |
| Device Name:
Classification: | CONCORD Plus™ Radiopaque Bone Cement
Per 21 CFR §888.3027 Polymethylmethacrylate
(PMMA) bone cement.
Product Code: NDN
Regulatory Class: II, Panel Code: Orthopedic 87 |
| Predicate(s):
Primary
Additional | CONCORD™ Radiopaque Bone Cement (K042168)
VertaPlex® HV Radiopaque Bone Cement (K091606) |
Purpose:
The purpose of this submission is to request clearance of the CONCORD Plus™ Radiopaque Bone Cement.
DEVICE DESCRIPTION:
The CONCORD Plus™ Radiopaque Bone Cement is a high-viscosity, radiopaque, self-curing, PMMA bone cement. It is provided sterile, as a two component system, a liquid component and a powder component which are mixed together prior to use to form the cement. The bone cement is intended for single use only.
INDICATION FOR USE:
CONCORD Plus™ Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Performance Data:
Performance data was conducted in accordance with the Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement, July 17, 2002. Performance data demonstrates substantial equivalence to the predicate.
Performance testing, chemical testing and handling properties were conducted to characterize CONCORD Plus™ Radiopaque Bone Cement compared to the
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predicate in compliance with ASTM D732-10. ASTM D5045-14. ASTM F2118-14. ASTM D638-10, ASTM F451-08, ASTM D2990-09, and ISO 5833:2002.
CONCORD Plus™ Radiopaque Bone Cement is provided sterile. The powder component is sterilized with gamma radiation to a Sterility Assurance Level (SAL) of 10°. The liquid component is sterilized with filtration methods to a SAL of 103. The outer packaging containing the liquid and powder components is sterilized by ethylene oxide gas to a SAL of 10-6.
Technological Characteristics:
The subject CONCORD Plus™ Radiopaque Bone Cement has the same fundamental scientific technology as the predicate CONCORD™ Radiopaque Bone Cement. The subject device has the same chemical composition, sterilization methods and meets the same pyrogen limit specification of ≤20 EU/device as the predicate. The subject CONCORD Plus™ is a high viscosity bone cement similar to the predicate VertaPlex HV Bone Cement.
Basis of Substantial Equivalence:
CONCORD Plus™ Radiopaque Bone Cement has been found to be substantially equivalent to the predicate device with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject bone cement to the predicate devices.