(132 days)
The 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 resulting from compression fracture, in order to provide stabilization of the collapsed vertebral body and pain relief. The following modifications are being made: Change to the formulation of the bone cement liquid component.
The provided text is a 510(k) premarket notification for a medical device: Vertebroplastic™ Radiopaque Bone Cement. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and testing results as would be typical for software or AI/ML-based devices.
Therefore, much of the requested information cannot be extracted directly from this document. The device is a physical bone cement, not a software or AI/ML device, so concepts like "test set," "training set," "ground truth experts," "adjudication method," and "MRMC study" are not applicable in the way they would be for digital health technologies.
However, I can extract information related to the device description and the basis of substantial equivalence.
Here's an attempt to answer the questions based on the provided text, noting where the information is not applicable or available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device based on "technological characteristics (chemical composition, material properties, performance characteristics, manufacture, packaging and sterilization)" and "intended use and indications for use."
Therefore, a table of acceptance criteria and reported device performance as commonly understood for digital health devices cannot be created directly from this text. The "performance" assessment is qualitative, comparing the modified device to its predicate.
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 physical bone cement, not a software or AI/ML device that would undergo testing with a "test set" of data. The "study" mentioned is a comparison of characteristics to a predicate device.
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. The concept of "ground truth for a test set" is not relevant to the substantial equivalence review of this physical device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or a test set requiring adjudication in this context.
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 device, and no MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical bone cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The review focuses on material properties and chemical composition compared to a predicate, not on clinical outcomes or diagnostic accuracy requiring "ground truth" as typically defined for AI/ML devices.
8. The sample size for the training set
Not applicable. This is a physical bone cement, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable.
Summary of what can be extracted from the document regarding the "study" for this device:
The "study" or justification for this device meeting its criteria is a demonstration of substantial equivalence to previously cleared predicate devices.
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Predicate Devices:
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Basis of Substantial Equivalence:
- Technological Characteristics: Chemical composition, material properties, performance characteristics, manufacture, packaging, and sterilization. (The document mentions a "Change to the formulation of the bone cement liquid component" as the modification being made.)
- Intended Use and Indications for Use: The intended use and indications for use are stated to be similar (identical) to the predicate Vertebroplastic™ Radiopaque Bone Cement (K043406).
In essence, the "acceptance criteria" here implicitly are that the modified device's characteristics and intended use are sufficiently similar to the predicate devices such that it raises no new questions of safety or effectiveness. The "study" involves comparing the modified formulation against the established properties of the cleared predicate devices. Specific quantitative performance data from a clinical trial or bench test proving performance against strict numerical acceptance criteria are not presented in this summary, as is typical for 510(k)s seeking substantial equivalence for material modifications.
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SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Spine, Inc.325 Paramount DriveRaynhamMA 02767-0350 | NOV 21 2007 | |
|---|---|---|---|
| 510(k) CONTACT: | Sharon StarowiczDirector of Regulatory Affairs | ||
| TRADE NAME: | Vertebroplastic™ Radiopaque Bone Cement | ||
| COMMON NAME: | Polymethyl Methacrylate (PMMA) Bone Cement | ||
| CLASSIFICATION: | Class II; 21 CFR 888.3027 | ||
| DEVICE PRODUCT CODE: | NDN | ||
| SUBSTANTIALLY EQUIVALENTDEVICES: | Vertebroplastic™ Radiopaque Bone Cement (K043406)SmartSet GMV Endurance Gentamicin Bone Cement(K033382). |
DEVICE DESCRIPTION:
Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects resulting from compression fracture, in order to provide stabilization of the collapsed vertebral body and pain relief. The following modifications are being made:
Change to the formulation of the bone cement liquid component.
INTENDED USE AND INDICATIONS:
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).
BASIS OF SUBSTANTIAL EQUIVALENCE:
The substantial equivalence of modified Vertebroplastic™ Radiopaque Bone Cement to the identified predicate devices is demonstrated by its similarity in terms of technological characteristics (chemical composition, material properties, performance characteristics, manufacture, packaging and sterilization) to the Vertebroplastic ™ Radiopaque Bone Cement manufacture, packaging and stermization) is no verconton - Trackepages - President - Premientalized by institution (K1043406) and SmartSet GMT Endirance Geneament Boller (Called (Called (CNS 0) Start
similarity in terms of intended use and indications for use to the Vertebroplastic ™ Radi Bonc Cement (K043406).
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Image /page/1/Picture/12 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 symbol resembling an abstract caduceus, featuring three curved lines that suggest a staff with a serpent winding around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2007
Depuy Spine, Inc. % Ms. Sharon Starowicz Director of Regulatory Affairs 325 Paramount Drive Raynham, MA 02767-0350
Re: K071927
Trade/Device Name: Vertebroplastic™ Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Names: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, LOD Dated: November 1, 2007 Received: November 2, 2007
Dear Ms. Starowicz:
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 - Ms. Sharon Starowicz
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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000005
Indications for Use Statement
510(k) Number (if known):
Device Name: Vertebroplastic™ Radiopaque Bone Cement
Indications for Use:
The 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, my elama),
Prescription Use X (Part 21 CFR 801.Subpart D) 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)
Houbare Bonem
(Division Sign-Off) (Division Sign of General, Restorative, Division Neurological Devices
510(k) Number K071927
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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.”