(145 days)
Not Found
No
The summary describes a bone cement and its intended use, with no mention of AI or ML technology in the device description, intended use, or any other section.
No
The device is a bone cement used for the fixation of pathological fractures, which is a structural component in a medical procedure, not a device that itself provides therapy.
No
The "Intended Use / Indications for Use" states that the device is "intended for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures." This describes a treatment or fixation device, not a device used for diagnosis.
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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a bone cement used for fixing vertebral fractures during surgical procedures (vertebroplasty or kyphoplasty). This is a material implanted into the body, not a test performed on a sample taken from the body.
Therefore, based on the provided information, the Parallax® Acrylic Resin Cartridge with TRACERS-Ta 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 Cartridge with TRACERS-Ta 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-Ta 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
Not Found
Key Metrics
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
Image /page/0/Picture/1 description: The image shows the logo for ArthroCare Corporation. The logo consists of a stylized graphic to the left of the company name. The graphic is composed of several curved lines that converge to form a circular shape. The text "ArthroCare" is in a bold, sans-serif font, with "Corporation" in a smaller font size below it.
510(k) Summary
JUL 1 2 2006
ArthroCare Corporation Parallax® Acrylic Resin Cartridge with TRACERS-Ta
| 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: | February 15, 2006 |
Device Description
| Classification: | PMMA Bone Cement: Class II per 21 CFR
888.3027 |
|----------------------|------------------------------------------------------------------|
| Trade Name: | Parallax ® Acrylic Resin Cartridge with
TRACERS-Ta |
| Device Code: | NDN |
| Generic/Common Name: | Bone Cement |
Predicate Device
| Parallax ® Acrylic Resin with TRACERS ® -Ta | K050864 |
|---|---|
| ------------------------------------------------------------------- | --------- |
Parallax® Acrylic Resin with TRACERS®-Ta
Parallax® Acrylic Resin Cartridge with TRACERS® K050864 K053180
Intended Use
Parallax® Acrylic Resin Cartridge with TRACERS-Ta 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 Description
Parallax® Acrylic Resin Cartridge with TRACERS-Ta is an opacified polymethylmethacrylate bone cement.
Substantial Equivalence
The subject device is substantially equivalent to the ArthroCare Parallax Acrylic Resin with TRACERS-Ta (K050864) and the Parallax Acrylic Resin Cartridge with TRACERS (K053180).
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2006
Arthrocare Corporation, Inc. % Ms. Valerie Defiesta-Ng Director of Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K060425
Trade/Device Name: Parallax Acrylic Resin Cartridge with Tracers - Ta Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: June 1, 2006 Received: June 2, 2006
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) I ma letter notification. The FDA finding of substantial equivalence of your device to a legally premaince noticate 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 in you attine 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 other general 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,
Herbert Lemmercus
Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known):
Device Name:
Parallax® Acrylic Resin Cartridge with TRACERS-Ta
Indications for Use:
Parallax® Acrylic Resin Cartridge with TRACERS-Ta 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 CDHH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K060425 | xii |
|---|---|---|
| --------------- | --------- | ----- |