(215 days)
Not Found
No
The summary describes a mechanical device used to create a void and deliver bone cement. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device is used to create a void in the vertebral body and fill it with bone cement to treat painful pathological vertebral body compression fractures, which directly provides a therapeutic effect.
No
The device is described as a vertebral augmentation device used to create a void and fill it with bone cement during kyphoplasty procedures. It is a therapeutic device, not a diagnostic one.
No
The device description and performance studies clearly indicate this is a physical medical device used in a surgical procedure, involving components like needles and bone cement. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure performed in vivo (within the body) to treat vertebral compression fractures. It involves creating a void in the vertebral body and filling it with bone cement.
- Device Description: The device description reinforces its use in a surgical procedure to manipulate bone and deliver bone cement.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
IVD devices are specifically designed for testing biological samples to provide information about a person's health status. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The ArthroCare® Parallax® Contour® Vertebral Augmentation Device when used with the access needle kits are indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body and fill the void with Parallax Acrylic Resin (bone cement). The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.
Product codes
NDN, OAR, HXG
Device Description
The ArthroCare Parallax Contour Vertebral Augmentation Device is used to disrupt cancellous bone and create a void in the vertebral body and fill the void with Parallax Acrylic Resin (bone cement) during kyphoplasty or vertebral augmentation procedures.
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
- Pre-clinical cadaveric study: Evaluated the size of the void created by the Contour and predicate devices, and the volume of Parallax PMMA bone cement delivered during vertebral augmentation. Showed equivalence in performance.
- Study on Parallax bone cement volume distribution in human cadaver fractured vertebral discs: Compared a test group using the Contour device to create a void prior to vertebral augmentation with bone cement, and a control group where the Contour device was not used. Demonstrated that the Contour device successfully creates a void and allows for significantly more cement delivery.
- Study on void creation in simulated human foam bone blocks: Compared the performance of the Contour and predicate devices. Showed similar void volumes with no statistically significant differences.
- Clinical study: Evaluated clinical efficacy of the Contour device used with PMMA bone cement to fill voids in percutaneous vertebral augmentation.
- Volume of void created: 0.33 to 2.02 cc for individual patients.
- Volume of PMMA instillation: 2.9 to 8.5 cc.
- PMMA extravasation: Four cases demonstrated imaging evidence of extravasation into paravertebral veins; all four cases were asymptomatic.
- Pain score: Mean VAS pain score was significantly reduced after follow-up (p
§ 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
2951580
SEP 2 1 2010
ArthroCare® Corporation Parallax® Contour® Vertebral Augmentation Device
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523
Director, Regulatory Affairs
Valerie Defiesta-Ng
408.736.0224
February 17, 2010
Establishment Registration Number:
Contact Person:
Contact Phone Number:
Date Prepared:
Device Description
Trade Name:
Classification Name:
Parallax® Contour® Vertebral Augmentation Device
Class II Polymethylmethacrylate (PMMA) bone cement (Section 888.3027) Pro-codes NDN:
Class 1 Cement dispenser (Section 888.4200) Pro-codes OAR; and
Class I Orthopedic Manual Surgical Instrument (Section 888.4540) Pro-codes . HXG
Predicate Devices
Parallax Contour Osteotome Access Needle Kits A V A flex Vertebral Augmentation Needle Class 1 exempt Class I exempt K072133
1
Product Description
The ArthroCare Parallax Contour Vertebral Augmentation Device is used to disrupt cancellous bone and create a void in the vertebral body and fill the void with Parallax Acrylic Resin (bone cement) during kyphoplasty or vertebral augmentation procedures.
Intended Uses
The Parallax Contour Vertebral Augmentation Device when used with the access needle kits are indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body and fill the void with Parallax Acrylic Resin (bone cement). The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.
Substantial Equivalence
In establishing substantial equivalence to the predicate device, ArthroCare compared the indications for use, performance specifications, and technology of the subject device to the predicate device. Functional performance testing of the device included torque, insertion and withdrawal, flexure, device attachment/deployment/removal and mechanical displacement of bone have been completed to demonstrate the mechanical characteristics of the device.
A pre-clinical cadaveric study was conducted to evaluate the size void created by the Contour and predicate devices, as well as the volume of Parallax PMMA bone cement delivered during vertebral augmentation. This study demonstrated equivalence in performance of the Contour and predicate devices when used in cadaveric vertebral bodies. In addition, studies were also conducted to characterize Parallax bone cement volume distributed in human cadaver fractured vertebral discs. The test group used the Contour device to create a void prior to vertebral augmentation with bone cement; in the control group the Contour device was not used prior to vertebral augmentation. Comparative data between test group and the control group is reported in terms of relative fill of cement volume per vertebral body volume. Results demonstrates the Contour may be use to successfully create a void in the vertebral body, and that use of Contour device prior to cement augmentation allows significantly more cement delivery into the vertebral body compared to the standard vertebroplasty procedure. Testing was also conducted to compare the performance of the Contour and predicate devices in terms of volume of void created in simulated human foam bone blocks. Based on the results of the study, the void volumes were all similar in size, and no statistically significant differences were noted between the two devices. The pre-clinical studies demonstrate the Contour device performs equivalent to the predicate device.
A clinical study was conducted to evaluate clinical efficacy of the Contour device used in conjunction with PMMA bone cement to fill voids that have been created during perculaneous vertebral augmentation. The outcome showed the volume of the void percularious vertebral body using the Contour ranged from 0.33 to 2.02 cc for individual patients; the volume of PMMA instillation ranged from 2.9 to 8.5 cc; four cases
2
demonstrated imaging evidence of PMMA extravasation into the paravertebral veins, all four cases were asymptomatic; and after the mean follow-up period, the mean VAS pain score was significantly reduced (dependent t-test, p