(63 days)
Not Found
No
The description explicitly states the system consists of "manual, single-use disposable instruments" and does not mention any computational or data-driven components indicative of AI/ML.
No.
The device is a delivery system for bone cement, not the therapeutic agent itself. It is used to inject bone cement for the fixation of vertebral body fractures, which is a therapeutic procedure but the device itself is an instrument for that procedure.
No
The device is described as a "Cement Delivery System" used for the "fixation of pathological fractures" by injecting acrylic resin. Its function is to deliver treatment material, not to diagnose a condition.
No
The device description explicitly states that the system consists of "general instruments" and "manual, single-use disposable instruments," indicating it is a hardware-based delivery system for bone cement.
Based on the provided information, the Parallax® EZFlow™ Cement Delivery System 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.
- Device Function: The Parallax® EZFlow™ Cement Delivery System is a delivery system for bone cement used in surgical procedures (vertebroplasty and kyphoplasty) to fix vertebral fractures. It is a surgical instrument used in vivo (within the body) during a procedure, not a test performed on a sample in vitro (outside the body).
- Intended Use: The intended use clearly describes a surgical procedure for fixing fractures, not a diagnostic test.
- Device Description: The description details a system of manual, single-use disposable instruments for injecting bone cement, not a diagnostic assay or testing device.
Therefore, the Parallax® EZFlow™ Cement Delivery System falls under the category of a surgical device or instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Parallax® EZFlow™ Cement Delivery System is intended for use with Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta 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 (comma separated list FDA assigned to the subject device)
OAR, KIH
Device Description
Parallax® EZFlow™ Cement Delivery System is a delivery system for the Parallax Acrylic Resin with TRACERS and Parallax Acrylic Resin with TRACERS Ta. It is designed to provide surgeons with a means to inject Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. The EZFlow Cement Delivery System does not contain any bone cement material, as this system only consists of general instruments. All of the system components are manual, single-use disposable instruments.
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
surgeons
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)
In establishing substantial equivalence, ArthroCare evaluated the indications for use, functional testing, and prospective clinical data to demonstrate equivalence to the predicate devices. We believe the EZFlow Cement Delivery System is substantially equivalent to the currently marketed device in 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
§ 888.4200 Cement dispenser.
(a)
Identification. A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
510(k) Summary of Safety and Effectiveness ArthroCare Corporation Parallax® EZFlow™ Cement Delivery System
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: | July 1, 2005 |
Device Description
| Classification: | Cement Dispenser: Class I Exempt per 21 CFR 888.4200 |
|---|---|
| Trade Name: | Parallax ® EZFlow ™ Cement Delivery System |
| Device Code: | OAR and KIH |
| Generic/Common Name: | Cement Dispenser |
Predicate Devices
Parallax® Cement Injector Kit
Intended Use
Parallax® EZFlow™ Cement Delivery System is intended for use with Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACER Ta 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® EZFlow™ Cement Delivery System is a delivery system for the Parallax Acrylic Resin with TRACERS and Parallax Acrylic Resin with TRACERS Ta. It is designed to provide surgeons with a means to inject Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. The EZFlow Cement Delivery System does not contain any bone cement material, as this system only consists of general instruments. All of the system components are manual, single-use disposable instruments.
1
Substantial Equivalence
In establishing substantial equivalence, ArthroCare evaluated the indications for use, functional testing, and prospective clinical data to demonstrate equivalence to the predicate devices. We believe the EZFlow Cement Delivery System is substantially equivalent to the currently marketed device in its intended use.
2
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird in flight, composed of three curved lines.
JAN 3 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ArthroCare Corporation % Ms. Valerie DeFiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085
Re: K051820
Trade/Device Name: Parallax EXFlow Cement Delivery System Regulation Number: 21 CFR 888.4200 Regulation Name: Cement Dispenser Regulatory Class: Class I Exempt Product Code: OAR Dated: September 6, 2005 Received: September 6, 2005
Dear Ms. Defiesta-Ng:
This letter corrects our exempt letter of September 6, 2005.
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.
We note that your device exceeded the Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 CFR Part 888.9), and therefore required the submission and clearance of a premarket notification prior to commercial distribution in the United States. Future devices of this same type, that meet the exemption criteria and do not exceed the limitations of exemptions found in 21 CFR Part 888.9 will be exempt from the premarket notification requirements of the Act.
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
3
Page 2 - Ms. Valerie DeFiesta-Ng
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 I loase be deviloed that I Dr brains that your device complies with other requirements of the Act that I Drimas intatutes 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. production 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 premaince holicated 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/dsma/dsmamain.html
Sincerely vours,
Barbara Brown
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 3 – Ms. Valerie DeFiesta-Ng
Indications for Use
510(k) Number (if known): K051820
Device Name: Paralax® EXFlow™ Cement Delivery System
Indications For Use:
Parallax® EZFlow™ Cement Delivery System is intended for use with Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta 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 _____________________________________________________________________________________________________________________________________________________________ Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)