(73 days)
Not Found
No
The summary describes a bone cement and does not mention any AI or ML capabilities.
Yes
The device is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures, which are therapeutic interventions.
No
The device, Parallax Acrylic Resin with TRACERS® Ta, is described as an opacified polymethylmethacrylate (PMMA) bone cement indicated for the fixation of pathological fractures of the vertebral body. Its function is to fix fractures, not to diagnose conditions.
No
The device description clearly states it is a "polymethylmethacrylate (PMMA) bone cement," which 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 clearly states the device is for the "fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures." This is a surgical procedure performed in vivo (within the living body) to treat a physical condition.
- Device Description: The device is described as "opacified polymethylmethacrylate (PMMA) bone cement." This is a material used for structural support and fixation within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with biological specimens outside the body.
Therefore, Parallax Acrylic Resin with TRACERS® Ta is a medical device used for a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Parallax * Acrylic Resin with TRACERS® Ta 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 cancer, myleoma).
Product codes (comma separated list FDA assigned to the subject device)
NDN,LOD
Device Description
Parallax Acrylic Resin with TRACERS Ta is an opacified polymethylmethacrylate (PMMA) bone coment.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
ArthroCare Corporation Parallax® Acrylic Resin Kit with TRACERS* Ta Bone Cement Opacifier
General Information
| Submitter Name/Address: | ArthroCare Corporation
680 Vaqueros Avenue
Sunnyvale, CA 94085-3523 |
|------------------------------------|---------------------------------------------------------------------------|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng
Director, Regulatory Affairs |
| Date Prepared: | April 4, 2005 |
| Device Description | |
| Trade Name: | Parallax ' Acrylic Resin with TRACERS" Ta |
| Classification Name: | Bone Cement (21 CFR 888.3027) |
| Device Classification: | Class II
Panel: Orthopedic Devices |
Predicate Devices
Parallax® Acrylic Resin with TRACERS* K042947
Product Description
Parallax Acrylic Resin with TRACERS Ta is an opacified polymethylmethacrylate (PMMA) bone coment.
Intended Uses
Parallax Acrylic Resin with TRACERS Ta 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, myleoma).
N
1
Substantial Equivalence
Substantial Equivalence
This Special 510(k) proposes a material modification for the Parallax Acrylic Resin with This Special 510(k) proposes a materard in K042947 on December 27, 2004. The TKACERS, which was previously endaled in the secure and sterilization mulcations for use, technology princesses with TRACERS remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
Summal y of Safety and Enectricals:3
The modified Parallax Acrylic Resin with TRACERS, as described in this Special 510(k), The modified I aranax Neryne Researce device. The proposed modification in material is not a substantial change or modification, and docs not significantly affect the safety or efficacy of the device.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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" around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human figures or waves, creating a sense of movement and connection.
Public Health Service
JUN 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K050864
Trade/Device Name: Parallax® Acrylic Resin with TRACERS® TA Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN,LOD Dated: April 4, 2005 Received: April 5, 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 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.
3
Page 2 - Ms. Valerie Defiesta-Ng
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,
Miriam C. Provost, Ph.D.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 250 86 4
Device Name: Parallax " Acrylic Resin with TRACERS" Ta
Indications for Usc:
Parallax * Acrylic Resin with TRACERS® Ta 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 cancer, myleoma).
Prescription Use X Over-the-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Hupd Rlurlio
(Division Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________