(72 days)
Not Found
No
The summary describes a bone cement and its intended use in vertebroplasty/kyphoplasty. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The predicate device is also a bone cement.
Yes
The device is a bone cement intended for fixation of pathological fractures due to various conditions, which is a therapeutic intervention.
No
The provided text describes the device as a bone cement for fixing vertebral fractures, indicating a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a polymethylmethacrylate bone cement, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that the Parallax® Acrylic Resin Cartridge with TRACERS is a bone cement intended for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. This is a surgical implant/material used directly within the body, not for testing samples outside the body.
The information provided describes a device used in a surgical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
Parallax® Acrylic Resin Cartridge with TRACERS is intended 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).
Product codes
NDN
Device Description
Parallax® Acrylic Resin Cartridge with TRACERS is an opacified polymethylmethacrylate bone 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
Not Found
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)
Not Found
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.”
0
JAN 2 5 2006
Parallax® Acrylic Resin Cartridge with TRACERS
510(k) Summary ArthroCare Corporation
| General Information | |
|---|---|
| Manufacturer: | ArthroCare, Corporation |
| 680 Vaqueros Avenue | |
| Sunnyvale, CA 94085 | |
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng |
| Director, Regulatory Affairs | |
| Date Prepared: | November 11, 2005 |
| Device Description | |
| Classification: | PMMA Bone Cement: Class II per 21 CFR |
| 888.3027 | |
| Trade Name: | Parallax ® Acrylic Resin Cartridge With TRACERS |
| Device Code: | NDN |
| Generic/Common Name: | Bone Cement |
| Predicate Device | |
| Parallax ® Acrylic Resin with TRACERS ® : | K042947 |
Intended Use
Parallax® Acrylic Resin Cartridge with TRACERS is intended 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, mycloma).
Product Description
Parallax® Acrylic Resin Cartridge with TRACERS is an opacified polymethylmethacrylate bone cement.
Substantial Equivalence
The subject device is substantially equivalent to the ArthroCare Parallax Acrylic Resin with TRACERS (K042947).
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ින පොත් විසින් අනුව | Shine Lude, Ludiner 84085 0525 | Franch 408 736 1229 | The Schloseph | La
Image /page/0/Picture/14 description: The image shows the logo for ArthroCare Corporation. The logo consists of a stylized graphic on the left and the company name on the right. The graphic is made up of several curved lines that resemble a wave or a stylized sun. The text "ArthroCare" is in a bold, sans-serif font, and below it is the word "Corporation" in a smaller, lighter font.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines forming the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2006
Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthoCare Corp. 680 Vaqueros Ave. Sunnyvale, California 95408
Re: K053180
Trade/Device Name: Parallax Acrylic Resin Cartridge with Tracers Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: November 11, 2005 Received: November 14, 2005
Dear Ms. Defiesta-Ng:
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
2
Page 2 - Ms. Valerie Defiesta-Ng
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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
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 Statement
510(k) Number (if known):
KOS 3180
Device Name:
Parallax® Acrylic Resin Cartridge with TRACERS
Indications for Use:
Parallax® Acrylic Resin Cartridge with TRACERS is intended 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 (Part 21 CFR 801 Subpart D) X
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)
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(Division Sign-Off) (Division Sign of General, Restorative, Division rological Devices
510(k) Number_KOS3180