(142 days)
Vertaplex HV 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).
Vertaplex HV is Polymethyl Methacrylate cement used for the treatment of painful vertebral fractures based on the predicate device Stryker Vertaplex PMMA Radiopaque Bone Cement (Vertaplex). Vertaplex HV can be injected directly into the fractured vertebral body by either Vertebroplasty or Kyphoplasty procedures to relieve pain.
The provided text describes a 510(k) summary for the Stryker Vertaplex HV, a PMMA Bone Cement. The submission focuses on demonstrating substantial equivalence to a predicate device, the Stryker Vertaplex Radiopaque Bone Cement (K072118), rather than presenting a study proving performance against defined acceptance criteria in the context of an AI/algorithm-based medical device.
Therefore, many of the requested categories related to AI device performance evaluation (such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, and standalone performance) are not applicable to this document.
Here's an attempt to answer the questions based only on the provided text, primarily focusing on the "Safety and Effectiveness" section of the 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Same design, materials, and intended use as predicate device. | Vertaplex HV is "substantially equivalent in design, materials, intended use and performance to the predicate device." |
| Meets similar performance specifications as the predicate device. | "Testing shows that the device meets similar performance specifications as those for the predicate device." |
| Introduces no new types of issues of safety or effectiveness. | "No new types of issues of safety or effectiveness are introduced by using this device." |
| Composed of the same chemical components as predicate device. | "Stryker Vertaplex HV is composed of the same chemical components as Stryker Vertaplex PMMA Bone Cement." |
| Equivalent in performance to predicate device. | "and is equivalent in performance." |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable. This document describes a 510(k) submission for a bone cement device, not an AI device. The testing mentioned refers to physical/chemical properties and performance, not evaluation against a test set of data like an AI algorithm. No information about data provenance (country of origin, retrospective/prospective) is provided as it's not relevant to this type of device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth establishment by experts for a test set is relevant for AI/algorithm performance evaluation. This document describes a traditional medical device submission, where "ground truth" would relate to laboratory testing results or clinical outcomes, not expert interpretation of data for an algorithm.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations when establishing ground truth for evaluating AI/algorithm performance. This is not mentioned as it's not applicable to this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. MRMC studies are specific to evaluating AI-assisted diagnostic or interpretive devices involving human readers. This document is for a bone cement, not an AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This question pertains to AI algorithms. The device described, Stryker Vertaplex HV, is a physical bone cement, not an algorithm.
7. The Type of Ground Truth Used
- For the purpose of demonstrating substantial equivalence for this bone cement, the "ground truth" implicitly relies on physical, chemical, and mechanical testing results (e.g., meeting specifications for strength, setting time, radiopacity) that are deemed similar or equivalent to the predicate device. The document states, "Testing shows that the device meets similar performance specifications as those for the predicate device."
8. The Sample Size for the Training Set
- Not applicable. This question refers to AI model training. The document describes a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This question refers to AI model training. The document describes a physical medical device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters, seemingly a code or identifier. The sequence reads 'K09/606', with a forward slash separating the '09' from '606'. The handwriting is somewhat stylized, with rounded forms for the zeros and sixes.
4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 269 324 5412 www.stryker.com
OCT 2 3 2009
stryker
Instruments
510(k) Summary
| 510(k) Owner: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-324-5412 |
|---|---|
| Contact Person: | Becky E. DittyRegulatory Affairs Analyst |
| Registration No .: | 1811755 |
| Trade Name: | Stryker Vertaplex HV |
| Common Name: | PMMA Bone Cement |
| Classification Name: | Polymethylmethacrylate (PMMA) Bone Cement |
| Regulation Number: | $888.3027 |
| Predicate Device: | Stryker Vertaplex Radiopaque Bone Cement (K072118) |
| Device Description: | Vertaplex HV is Polymethyl Methacrylate cement used for the treatment ofpainful vertebral fractures based on the predicate device Stryker VertaplexPMMA Radiopaque Bone Cement (Vertaplex). Vertaplex HV can be injecteddirectly into the fractured vertebral body by either Vertebroplasty or Kyphoplastyprocedures to relieve pain. |
| Indications for Use: | Vertaplex HV Radiopaque Bone Cement is indicated for the fixation ofpathological fractures of the vertebral body using vertebroplasty or kyphoplastyprocedures.Painful vertebral compression fractures may resultfromosteoporosis, benign lesions (hemangioma), and malignant lesions (metastaticcancers, myeloma). |
| Substantial Equivalence(SE) Rational: | Stryker Vertaplex HV is composed of the same chemical components as StrykerVertaplex PPMA Bone Cement and is equivalent in performance. |
| Safety and Effectiveness: | Stryker Vertaplex HV is substantially equivalent in design, materials, intendeduse and performance to the predicate device, Stryker Vertaplex PMMA BoneCement (K072118). Testing shows that the device meets similar performancespecifications as those for the predicate device. No new types of issues ofsafety or effectiveness are introduced by using this device. |
| Submitted by: | Becky E. DittyRegulatory Affairs AnalystSignature |
| Date Submitted: | June 1, 2009 |
{1}------------------------------------------------
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 symbol featuring three abstract, wave-like shapes stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Instruments % Ms. Becky E. Ditty Regulatory Affairs Analyst 4100 E. Milham Avenue Kalamazoo, MI 49001
OCT 2 3 2009
Re: K091606
Trade/Device Name: Vertaplex HV Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, LOD Dated: October 6, 2009 Received: October 9, 2009
Dear Ms. Ditty:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
{2}------------------------------------------------
Page 2 - Ms. Becky E. Ditty
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm111800 html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Allo, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 (1)53) Pred. 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark M. Milkusson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Vertaplex HV ____________________________________________________________________________________________________________________________________________________
Indications for Use
Vertaplex HV 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 _ X (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)
FOR M. MELKERSON
(Bivision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091606
§ 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.”