(158 days)
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).
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.
The provided text is a 510(k) Premarket Notification for a medical device called Symphony™ VR Radiopaque Bone Cement. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving the device meets specific performance acceptance criteria in the way a clinical trial for an AI algorithm would.
Therefore, many of the requested points regarding acceptance criteria, study design, ground truth, and human reader performance are not applicable to this type of regulatory submission for a bone cement.
Here's an analysis of the provided information in the context of the questions:
1. A table of acceptance criteria and the reported device performance
-
Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical or diagnostic performance. Instead, the "acceptance criteria" are implied to be demonstrating substantial equivalence to legally marketed predicate devices in terms of:
- Intended Use
- Functional Characteristics (though not quantified with performance metrics)
- Material Properties (chemical composition)
- Biocompatibility
- Clinical Application
-
Reported Device Performance:
The document focuses on comparing the chemical composition of Symphony™ VR Radiopaque Bone Cement to its predicate devices. The key "performance" demonstrated here is the similarity in composition.Chemical Composition Symphony™ VR KyphX® HV-R Stryker Spineplex™ Howmedica Osteonics Surgical Simplex® P Powder PolymethylMethacrylate / MethylMethacrylate-styrenecopolymer 71.3% w/w 68.0% w/w 69.1% w/w Not provided for Simplex® Barium sulfate 28.0% w/w 30.0% w/w 30.0% w/w Not provided for Simplex® Benzoyl peroxide 0.7% w/w 2.0% w/w 0.9% w/w Not provided for Simplex® Liquid Methyl Methacrylate 99.0% v/v 99.1% v/v 97.4% v/v Not provided for Simplex® N: N Dimethyl-p-toluidine 1.0% v/v 0.9% v/v 2.6% v/v Not provided for Simplex® Hydroquinone 100 ppm 75 ppm 75 ± 15 ppm Not provided for Simplex® Note: The document states "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." which is not listed in the comparison table, but implies a known baseline for the manufacturer.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a medical device (bone cement) submission, not an AI algorithm. There is no "test set" of patient data in the context of diagnostic performance. The "test" here is demonstrating chemical and functional similarity to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is not an AI algorithm for diagnosis or image interpretation. "Ground truth" in the AI sense is not relevant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this submission is the established properties of the predicate devices and the chemical synthesis and characterization of the new device.
8. The sample size for the training set
- Not Applicable. This is not an AI algorithm, so there is no training set in the machine learning sense.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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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 AvenueChatham, NJ 07928 | ||
| Contact: | John P. CarrChief 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 bonecement made of the same chemical components as AdvancedBiomaterial Systems, Inc. CONCERT® Radiopaque Bone Cement.Symphony™ VR Radiopaque Bone Cement is provided as a two-component product. The polymer powder consists of a PMMAcopolymer (polymethyl methacrylate and methyl methacrylate-styrene copolymer) with barium sulfate as the radiopacifier andbenzoyl peroxide as the initiator. The liquid component consists ofmethyl methacrylate monomer, which includes hydroquinone as thestabilizer 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 |
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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) Bottleof Sterile Powder | 20 g (half-dose) Packetof Sterile Powder | 20 g (half-dose) Packetof Sterile Powder |
| PolymethylMethacrylate / MethylMethacrylate-styrenecopolymer | 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 ofSterile Liquid | 9.0g (half-dose) Vial ofSterile Liquid | 9.4 (half-dose) Vial ofSterile 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.
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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.
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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
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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
§ 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.”