(62 days)
Not Found
No
The summary describes a bone cement and its intended use, with no mention of AI or ML technology.
Yes.
The device is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures, which are medical treatments for pain and fractures.
No
The device is a bone cement used for the fixation of pathological fractures, which is a therapeutic rather than a diagnostic function. Its purpose is to treat fractures, not to identify or diagnose them.
No
The device description clearly states it is an "opacified polymethylmethacrylate 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 is for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a bone cement, which is a material implanted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
Therefore, Parallax® Acrylic Resin with TRACERS® is a medical device used in a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Parallax® Acrylic Resin with TRACERS® 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).
Product codes (comma separated list FDA assigned to the subject device)
NDN
Device Description
Parallax® Acrylic Resin 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)
Performance testing has been completed to demonstrate the substantial equivalence of the Parallax® Acrylic Resin with TRACERS® to the predicate device. The performance testing and device comparison demonstrated that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.
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
DEC 2 7 2004
ArthroCare Corporation Parallax® Acrylic Resin with TRACERS®
510(k) Summary of Safety and Effectiveness ArthroCare, Corporation Parallax® Acrylic Resin Kit with TRACERS® Bone Cement Opacifier
| General Information | |
|---|---|
| Manufacturer: | ArthroCare, Corporation |
| 680 Vaqueros Ave | |
| Sunnyvale, CA 94085 | |
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng |
| Director, Regulatory Affairs | |
| Date Prepared: | October 25, 2004 |
| Device Description | |
| Classification Name: | Bone Cement (21 CFR 888.3027) |
| Trade Name: | Parallax ® Acrylic Resin with TRACERS ® |
| Generic/Common Name: | Bone Cement |
| Predicate Device |
Predicate Device
Spineplex™ Radiopaque Bone Cement K032945
Intended Use
Parallax® Acrylic Resin with TRACERS® is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from ostcoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myleoma).
Product Description
Parallax® Acrylic Resin with TRACERS® is an opacified polymethylmethacrylate bone cement.
Substantial Equivalence
In establishing substantial equivalence to the predicate dcvice, ArthroCare compared the indications for use, materials, and mechanical properties of the subject device and the predicate device. Additionally, performance testing has been completed to demonstrate the substantial equivalence of the Parallax® Acrylic Resin with TRACERS® to the predicate device. The performance testing and device comparison demonstrated that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Public Health Service
DEC 2 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Valerie Defiesta-Ng Arthrocare Corp. 680 Vaqueros Ave. Sunnyvale, California 94085
Re: K042947
Trade/Device Name: Parallax® Acrylic Resin with Tracers® Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: October 25, 2004 Received: October 26, 2004
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.
2
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
uriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known): __ lCO4 2947 Device Name: Indications for Use:
Parallax® Acrylic Resin with TRACERS® 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).
Over-The-Counter Use Prescription Use 2 AND/OR (Part 21 CFR 801 Subpart D) (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 of ______________________________________________________________________________________________________________________________________________________________________
Miriam C. Provost
(Division Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________