(217 days)
Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects, in order to provide stabilization of the vertebral body and pain relief. Vertebroplastic™ Radiopaque Bone Cement has a low viscosity and long working and setting time
I am sorry, but the provided text is for a medical device called "Vertebroplastic™ Radiopaque Bone Cement," which is a polymethylmethacrylate (PMMA) cement used for filling spinal vertebral body defects. This is a physical product and not an AI/ML powered device. As such, the concepts of "acceptance criteria for an AI model," "sample size for test set," "ground truth," "MRMC study," or "training set" are not applicable to this document.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailed performance studies and acceptance criteria as would be found for an AI/ML device.
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PREMARKET NOTIFICATION [510(k)] SUMMARY
| Trade Name: | Vertebroplastic™ Radiopaque Bone Cement | JUL 1 5 2005 |
|---|---|---|
| Common Name: | Polymethylmethacrylate (PMMA) bone cement | |
| Classification Name: | Filler bone cement (for vertebroplasty) | |
| Regulatory Class: | Class II, per 21 CFR §888.3027, | |
| Device Code: | NDN | |
| 510k Sponser: | DePuy Spine, Inc.325 Paramount DriveRaynham, Massachusetts 02767-0350 | |
| Manufacturer: | DePuy International Limited, trading asDePuy CMWCornford RoadBlackpoolLancashire FY4 4QQUnited Kingdom | |
| Contact Person: | Sharon Starowicz,Director of Regulatory AffairsDePuy Spine, Inc.325 Paramount DriveRaynham, Massachusetts 02767-0350Tel.: (508) 828-2867; Fax: (508) 828-3797 | |
| Equivalent to: | KyphX® HV-R™ Bone Cement Model C01A (K041584)Stryker SpinePlex™ Radiopaque Bone Cement (K032945)Stryker Howmedica Surgical Simplex® P Radiopaque pre-packed inACM and MixEvac II (K002652)Cranioplastic™, acrylic cranioplasty material (K873689) | |
| Device Description: | Vertebroplastic™ Radiopaque Bone Cement is a self-curing,radiopaque, polymethylmethacrylate (PMMA) cement, for filling ofspinal vertebral body defects, in order to provide stabilization of thevertebral body and pain relief. Vertebroplastic™ Radiopaque BoneCement has a low viscosity and long working and setting time |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sharon Starowicz Director of Regulatory Affairs . DePuv Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350 JUL 1 5 2005
Re: K043406
Trade Name: Vertebroplastic Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Bone Cement for Vertebroplasty Regulatory Class: II Product Code: NDN Dated: June 8, 2005 Received: June 9, 2005
Dear Ms. Starowicz:
We have reviewed your Section 510(k) premarket notification of intent to market the device in diedicati We have reviewed your Section 910(x) promatice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regarry manation povice Amendments, or to commerce prof to May 26, 1776, the encenters with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of actived a devices that have been recuired in acceraaned while hall has aremarket approval application (PMA). and Cosment Act (Act) that to not require approval controls provisions of the Act. The You may, therefore, market the device, basject to the securements for annual registration, listing of general controls provisions of the Act moration requirement misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in can If your device is classified (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entroller of Color Sep. In addition, FDA may be found in the Code of Peachartergaming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated on a badevice complies with other requirements of the Act that FDA has made a determination that your star formistered by other Federal agencies. You must of any Federal Statutes and regulations animations or system on and listing (21 comply with an the Act s requirements, mercums, can and acturing practice requirements as set
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Page 2 - Sharon Starowicz
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. 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/cdrb/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Vertebroplastic™ Radiopaque Bone Cement
Indications for Use:
Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Evelin
(Division Sign-Off) Division of General, Restorative and Neurological Devices
51001, Monitor K043426
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§ 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.”