(158 days)
Not Found
No
The device description focuses on the chemical composition of a bone cement and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is used to fix pathological fractures, which is a therapeutic intervention.
B: No
E: The device is a bone cement used for the fixation of pathological fractures, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a bone cement, which is a physical material, not software.
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 and structural application within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a bone cement, a material used to fill and stabilize bone fractures. This is a physical material used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This bone cement does not fit that description.
N/A
Intended Use / Indications for Use
Symphony™ VR 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
NDN
Device Description
Symphony™ VR Radiopaque Bone Cement is a PMMA bone cement made of the same chemical components as Advanced Biomaterial Systems, Inc. CONCERT® Radiopaque Bone Cement. Symphony™ VR Radiopaque Bone Cement is provided as a two-component product. The polymer powder consists of a PMMA copolymer (polymethyl methacrylate and methyl methacrylate-styrene copolymer) with barium sulfate as the radiopacifier and benzoyl peroxide as the initiator. The liquid component consists of methyl methacrylate monomer, which includes hydroquinone as the stabilizer and N:N dimethyl-p-toluidine as the activator.
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)
Based on the device performance information provided in this premarket notification, SymphonyTM VR Radiopaque Bone Cement has been shown to be substantially equivalent to the currently marketed predicate devices. This device has the same intended use, functional characteristics, material properties, biocompatibility and clinical application as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
0
K 042168 7.0 PREMARKET NOTIFICATION 510(K) SUMMARY
| 510(k) Number: | TO BE ASSIGNED | ||
|---|---|---|---|
| Date Prepared: | August 10, 2004 | ||
| Applicant Information: | |||
| Applicant: | Advanced Biomaterial Systems, Inc. | ||
| 100 Passaic Avenue | |||
| Chatham, NJ 07928 | |||
| Contact: | John P. Carr | ||
| Chief Operating Officer | |||
| Telephone: | |||
| Facsimile: | (973) 635-9040 | ||
| (973) 635-9878 | |||
| Registration: | To be assigned | ||
| Device Information: | |||
| Trade Name: | Symphony™ VR Radiopaque Bone Cement | ||
| Common Name: | PMMA Bone Cement (For Vertebroplasty) | ||
| Product Code: | NDN | ||
| Classification Name: | Filler, Bone Cement (For Vertebroplasty) | ||
| Regulation Class: | Class II | ||
| Regulation Number: | 21 CFR §888.3027 | ||
| Device Description: | Symphony™ VR Radiopaque Bone Cement is a PMMA bone | ||
| cement made of the same chemical components as Advanced | |||
| Biomaterial Systems, Inc. CONCERT® Radiopaque Bone Cement. |
Symphony™ VR Radiopaque Bone Cement is provided as a two-
component product. The polymer powder consists of a PMMA
copolymer (polymethyl methacrylate and methyl methacrylate-
styrene copolymer) with barium sulfate as the radiopacifier and
benzoyl peroxide as the initiator. The liquid component consists of
methyl methacrylate monomer, which includes hydroquinone as the
stabilizer and N:N dimethyl-p-toluidine as the activator. | | |
| Predicate Devices: | K033801: | Kyphon Inc. - KyphX® HV-R Bone Cement | |
| | K032945: | Stryker Spineplex™ Radiopaque Bone Cement | |
of
1
Howmedica Osteonics Surgical Simplex® P N017004: Radiopaque Bone Cement
Symphony™ VR Radiopaque Bone Cement is indicated for the Intended Use: 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).
The following table compares the chemical composition of Symphony™ VR Radiopaque Bone Cement compared to the predicate devices.
| Chemical Composition | Symphony™ VR | KyphX® HV-R | Stryker Spineplex™ |
|---|---|---|---|
| Powder | 20 g (half-dose) Bottle | ||
| of Sterile Powder | 20 g (half-dose) Packet | ||
| of Sterile Powder | 20 g (half-dose) Packet | ||
| of Sterile Powder | |||
| Polymethyl | |||
| Methacrylate / Methyl | |||
| Methacrylate-styrene | |||
| copolymer | 71.3% w/w | 68.0% w/w | 69.1% w/w |
| Barium sulfate | 28.0% w/w | 30.0% w/w | 30.0% w/w |
| Benzoyl peroxide | 0.7% w/w | 2.0% w/w | 0.9% w/w |
| Liquid | 8.2g (half-dose) Vial of | ||
| Sterile Liquid | 9.0g (half-dose) Vial of | ||
| Sterile Liquid | 9.4 (half-dose) Vial of | ||
| Sterile Liquid | |||
| Methyl Methacrylate | 99.0% v/v | 99.1% v/v | 97.4% v/v |
| N: N Dimethyl-p- | |||
| toluidine | 1.0% v/v | 0.9% v/v | 2.6% v/v |
| Hydroquinone | 100 ppm | 75 ppm | 75 ± 15 ppm |
Summary:
Based on the device performance information provided in this premarket notification, SymphonyTM VR Radiopaque Bone Cement has been shown to be substantially equivalent to the currently marketed predicate devices. This device has the same intended use, functional characteristics, material properties, biocompatibility and clinical application as the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white emblem or seal. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the outer edge. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked on top of each other.
Public Health Service
JAN 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John P. Carr Chief Operating Officer Advanced Biomaterial Systems 100 Passaic Avenue Chatham, New Jersey 07928
Re: K042168
Trade/Device Name: Symphony™VR Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate Bone Cement Regulatory Class: II Product Code: NDN Dated: December 17, 2004 Received: December 20, 2004
Dear Mr. Carr:
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.
3
Page 2 - Mr. John P. Carr
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A Milhern
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Symphony™ VR Radiopaque Bone Cement Device Name:
Indications For Use:
Symphony™ VR 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).
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (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)
Mark N. Melkerson
Division of General, Restorative, and Neurological Devices
510(k) Number