(128 days)
Vertaplex Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty of kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Vertaplex is Polymethyl Methacrylate cement used for the treatment of painful vertebral fractures based on the predicate device Spineplex. Vertaplex can be injected directly into the fractured vertebral body by either Vertebroplasty or Kyphoplasty procedures to relieve pain.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, or a study proving the device meets acceptance criteria in the way you've outlined.
The document is a 510(k) summary for a medical device (Stryker Vertaplex Radiopaque Bone Cement). It focuses on demonstrating substantial equivalence to a predicate device (Stryker Spineplex Radiopaque Bone Cement).
Here's what the document does state, which is relevant to your request, but doesn't fully answer it:
- Performance Standards: "Stryker Vertaplex has been developed in accordance with the FDA Guidance document entitled "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement."" This implies that certain performance characteristics relevant to PMMA bone cement are expected to be met, as per the guidance document. However, the specific acceptance criteria from that guidance are not detailed in this 510(k) summary.
- Safety and Effectiveness: "In vitro testing shows that the device meets similar performance specifications as those for the predicate device." This indicates that some form of testing was done to compare its performance to the predicate, but again, the specific results, acceptance criteria, or a detailed study description are not provided.
- Biocompatibility: "All appropriate biocompatibility tests have been performed on Vertaplex and have met the standard requirements." This confirms biocompatibility testing was performed and met standards, but doesn't specify the tests or criteria.
The 510(k) process primarily relies on demonstrating equivalence rather than exhaustive clinical trials for de novo authorization. Therefore, the detailed study design (like sample sizes, ground truth establishment, MRMC studies, etc.) you're asking about is not typically part of what's presented in a 510(k) summary for this type of device.
Therefore, I cannot populate your table or answer most of your detailed questions because the provided text does not contain that information.
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OEC * 7 2007
Image /page/0/Picture/1 description: The image shows the text "K072/18" in a handwritten style, with the "K" being larger than the other characters. Below this, the word "stryker" is written in a bold, sans-serif font. A registered trademark symbol is present to the right of the word "stryker".
4100 E. Milham Avenue Kalamazoo, MI 49001 t: 269 323 7700 f: 800 965 6505 www.stryker.com
510(k) Summary
Instruments
As required by section 21 CFR 807.92(c)
| Device Sponsor: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001269-323-7700Registration No.: 1811755 |
|---|---|
| Device Name: | Trade Name: Stryker Vertaplex Radiopaque Bone CementCommon Name: PMMA Bone CementClassification Name: Polymethylmethacrylate (PMMA) bone cement21 CFR§ 888.3027, LOD, NDN |
| Predicate Devices: | Stryker Spineplex Radiopaque Bone Cement - K032945 |
| Description: | Vertaplex is Polymethyl Methacrylate cement used for the treatment of painfulvertebral fractures based on the predicate device Spineplex. Vertaplex can beinjected directly into the fractured vertebral body by either Vertebroplasty orKyphoplasty procedures to relieve pain. |
| Intended Use: | Vertaplex Radiopaque Bone Cement is indicated for the fixation of pathologicalfractures of the vertebral body using vertebroplasty of kyphoplasty procedures.Painful vertebral compression fractures may result from osteoporosis, benignlesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). |
| Biocompatibility: | All appropriate biocompatibility tests have been performed on Vertaplex andhave met the standard requirements. |
Substantial Equivalence (SE) Rational: Stryker Vertaplex PMMA Bone Cement is made of the same chemical components as Stryker Spineplex.
Performance Standards: Stryker Vertaplex has been developed in accordance with the FDA Guidance document entitled "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement."
Safety and Effectiveness: Stryker Vertaplex is substantially equivalent in design, materials, intended use and performance characteristics to the predicate device, Spineplex (K032945). In vitro testing shows that the device meets similar performance specifications as those for the predicate device. No new issues of safety or effectiveness are introduced by using this device.
Signed:
Jean W. Sheppard
Regulatory Analyst
Dated: 7-26-07
Section 5 -- Page 2 of 2
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Instruments % Ms. Jean W. Sheppard Regulatory Analyst 4100 E. Milham Avenue Kalamazoo, MI 49001
DEC - 7 2007
Re: K072118
Trade/Device Name: Vertaplex Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Names: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, LOD Dated: November 28, 2007 Received: November 29, 2007
Dear Ms. Sheppard:
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. Jean W. Sheppard
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 yours.
Mark M. Milliman
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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Indications for Use
510(k) Number (if known): _KOJZI) V
Device Name: Vertaplex Radiopaque Bone Cement
Indications for Use:
Vertaplex Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty of kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number_K072118
§ 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.”