(53 days)
Not Found
No
The summary describes a mechanical system for delivering bone cement and includes mechanical testing results, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is indicated to deliver bone cement for the treatment of compression fractures of a vertebral body, which is a therapeutic intervention.
No
The device is described as a system to deliver bone cement for treating compression fractures, which is a therapeutic intervention, not a diagnostic one.
No
The summary describes a "Vertebroplasty System" which includes mechanical testing of devices ("CDO and LP2118 devices") for insertion into bone and delivery of bone cement. This clearly indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver bone cement legally cleared for use in the spine for the treatment of compression fractures of a vertebral body." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: While the description is "Not Found," the intended use clearly indicates a device used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing. The device's function is purely mechanical – delivering bone cement.
Therefore, the EBI® Vertebroplasty Systems are a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EBI® Vertebroplasty Systems are indicated to deliver bone cement legally cleared for use in the spine for the treatment of compression fractures of a vertebral body.
Product codes
LOD, NDN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine
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)
Mechanical testing of the EBI® Vertebroplasty Systems was conducted which demonstrates that the CDO and LP2118 devices conform to their design specifications. This testing demonstrated the CDO and LP27M Systems' ability to mechanically withstand insertion into a bony site and to deliver bone cement to the bony site. In all instances, the Vertebroplasty Systems functioned as intended and the test results obtained were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(k) SUMMARY
EBI, L.P.'s
EBI® Vertebroplasty Systems
| SUBMITTER: | EBI, L.P. |
|---|---|
| ADDRESS: | 100 Interpace Parkway |
| Parsippany, NJ 07054 | |
| PHONE: | (973) 299-9300 |
| FAX: | (973) 257-0232 |
| CONTACT PERSON: | Debra L. Bing |
| DATE PREPARED: | January 16, 2006 |
| TRADE NAME: | EBI® Vertebroplasty Systems |
| COMMON NAME: | Vertebral Body Cement Dispenser |
| CLASSIFICATION NAME: | PMMA Bone Cement, 21 CFR 888.3027 |
| CLASSIFICATION #: | Class II |
| PRODUCT CODE: | LOD, NDN |
| PREDICATE DEVICES: | Stryker Bone Biopsy System cleared under |
| K032943 on December 17, 2003 | |
| Abbott Spine Spinnaker System cleared under | |
| K052638 on November 7, 2005 | |
| Medtronic Sofamor Danek Equestra System | |
| cleared under K040483 on July 23, 2004 |
INTENDED/INDICATIONS FOR USE:
The EBI® Vertebroplasty Systems are indicated to deliver bone cement legally cleared for use in the spine for the treatment of compression fractures of a vertebral body.
Kobo148
1
TECHNOLOGICAL CHARACTERISTICS:
Performance Testing
Mechanical testing of the EBI® Vertebroplasty Systems was conducted which demonstrates that the CDO and LP2118 devices conform to their design specifications. This testing demonstrated the CDO and LP27M Systems' ability to mechanically withstand insertion into a bony site and to deliver bone cement to the bony site. In all instances, the Vertebroplasty Systems functioned as intended and the test results obtained were as expected.
Substantial Equivalence
The EBI® Vertebroplasty Systems are safe and offective as the predicate devices and have the same intended uses and similar indications, technological characteristics and principles of operation as the predicate devices. The minor technological differences between the Vertebroplasty components and the predicate devices raise no new issues of safety or effectiveness. Analysis data demonstrate that the Vertebroplasty Systems, their dimensions and materials are as safe and effective as the Stryker Bone Biopsy, Abbott Spinnaker and Medtronic Sofamor Danek Equestra systems. Thus, the Vertebroplasty Systems are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)". The text is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2006
EBI, L.P. c/o Ms. Debra L. Bing Director of Regulatory Affairs 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K060148
Trade/Device Name: EBI Vertebroplasty Systems Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: January 18, 2006 Received: January 19, 2006
Dear Ms. Bing:
:
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. Bing
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.
Helmut Lener
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K060148
Device Name: EBI® Vertebroplasty Systems
Indications for Use:
The EBI Vertebroplasty Systems are indicated to deliver bone cement legally cleared for use in the spine for the treatment of compression fractures of a vertebral body.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helut Semen
(Division Sign-Off)
Page __ of ___________________________________________________________________________________________________________________________________________________________________
Division of General, Restorative, and Neurological Devices
510(k) Number K060148