(142 days)
Not Found
No
The summary describes a physical bone cement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for the "fixation of pathological fractures," which is a medical intervention aimed at treating a condition and restoring function.
No
The device description indicates that the Radiopaque Bone Cement is used for the fixation of pathological fractures by being injected into the vertebral body, which is a treatment or therapeutic action, not a diagnostic one.
No
The device description clearly states it is a self-curing acrylic comprised of two sterile components (liquid and powder), which are mixed to form the cement. This is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of pathological fractures of the vertebral body." This is a therapeutic procedure performed in vivo (within the living body).
- Device Description: The device is a "self-curing acrylic that a surgeon uses to inject into the vertebral body of a patient." This describes a material used directly on or within the patient's body for structural support.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The description of this bone cement does not involve any of these activities.
Therefore, this device is a therapeutic device used directly on the patient, not an IVD.
N/A
Intended Use / Indications for Use
Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body.
Product codes
NDN
Device Description
Radiopaque Bone Cement is a self-curing acrylic that a surgeon uses to iniect into the vertebral body of a patient with pathological fractures within a vertebral body. It is comprised of two sterile components (liquid and powder), which are mixed to form the cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebral body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing demonstrated that the proposed Radiopaque Bone Cement is substantially equivalent to currently marketed Spineplex with regard to functional characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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MAY I 1 2005
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Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.689.8410
Image /page/0/Picture/4 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic of four curved lines above the company name. The text "CardinalHealth" is written in a bold, sans-serif font.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Radiopaque Bone Cement
Cardinal Health Sponsor: 1430 Waukegan Road McGaw Park, IL 60085
Sharon Nichols Manager, Regulatory Affairs
(847) 578-6610 Telephone:
Date Prepared: December, 2004
Product Trade Name:
Polymethyl Methacrylate (PMMA) Common Name:
Classification: Predicate Device:
Intended Use:
Contact:
Substantial Equivalence:
Description:
Summary of testing:
Non-clinical Test Results:
McGaw Park, IL 60085
Sharon Nichols
Radiopaque Bone Cement
Class II per 21 CFR §882.5300
Stryker Spineplex Radiopaque Bone Cement
ger, Regulatory Affairs
(447) 578-6610
Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body.
This device is substantially equivalent to Stryker Spineplex Radiopaque Bone Cement (K032945).
Radiopaque Bone Cement is a self-curing acrylic that a surgeon uses to iniect into the vertebral body of a patient with pathological fractures within a vertebral body. It is comprised of two sterile components (liquid and powder), which are mixed to form the cement.
Based on the product performance information provided to FDA, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.
Performance testing demonstrated that the proposed Radiopaque Bone Cement is substantially equivalent to currently marketed Spineplex with regard to functional characteristics.
00174
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAY 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sharon Nichols Regulatory Affairs Manager Cardinal Health 1430 Waukegan Road, WM McGaw Park, Illinois 60085
Re: K043518
Trade/Device Name: Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: April 25, 2005 Received: April 26, 2005
Dear Ms. Nichols:
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 Mav 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 docs 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 Nichols
This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter with cation. The FDA finding of substantial equivalence of your device to a legally premaince notificate 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/industry/support/index.html.
Sincerely yours,
Hypt Clurdu
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Cardinal Health 1430 Waukegan Road, WM McGaw Park, Illinois 60085 847.689.8410 main 847,785,2506 fax
CardinalHealth
Indications for Use
ﯿﮯ
510(k) Number (if known):____K043518
Device Name:_Radiopaque Bone Cement
Indications For Use:
Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body.
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) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K043518 |