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.

Device Description

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AI/ML Overview

This document describes the acceptance criteria and study proving the EBI® Vertebroplasty Systems meet these criteria.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Ability to mechanically withstand insertion into a bony site.	"The CDO and LP27M Systems' ability to mechanically withstand insertion into a bony site" was demonstrated. "In all instances, the Vertebroplasty Systems functioned as intended and the test results obtained were as expected."
Ability to deliver bone cement to the bony site.	"The CDO and LP27M Systems' ability...to deliver bone cement to the bony site" was demonstrated. "In all instances, the Vertebroplasty Systems functioned as intended and the test results obtained were as expected."
Conformance to design specifications.	"Mechanical testing of the EBI® Vertebroplasty Systems was conducted which demonstrates that the CDO and LP2118 devices conform to their design specifications."
Substantial equivalence to predicate devices (Stryker Bone Biopsy System, Abbott Spine Spinnaker System, Medtronic Sofamor Danek Equestra System).	"The EBI® Vertebroplasty Systems are safe and effective 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."

Study Details

Sample size used for the test set and the data provenance: The document mentions "Mechanical testing" of the EBI® Vertebroplasty Systems, specifically citing "CDO and LP2118 devices" and "CDO and LP27M Systems." However, specific sample sizes (e.g., number of devices tested, number of test runs) are not provided. The data provenance is not explicitly stated beyond being internal company testing ("Mechanical testing... was conducted"). It is implied to be a laboratory-based, prospective testing scenario.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The study involved mechanical performance testing against design specifications, not expert interpretation of outputs.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This was mechanical performance testing, not a study requiring adjudication of expert opinions.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document pertains to a medical device for delivering bone cement, not an AI-based diagnostic or analysis tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm. The "standalone" performance refers to the device's mechanical function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the mechanical testing was the predefined "design specifications" of the devices and the intended functional performance (withstanding insertion, delivering cement).
The sample size for the training set: Not applicable. This is a mechanical device, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable. As above, this is a mechanical device.

Summary

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510(k) SUMMARY

EBI, L.P.'s

EBI® Vertebroplasty Systems

SUBMITTER:	EBI, L.P.
ADDRESS:	100 Interpace ParkwayParsippany, 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 underK032943 on December 17, 2003Abbott Spine Spinnaker System cleared underK052638 on November 7, 2005Medtronic Sofamor Danek Equestra Systemcleared 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

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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.

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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.

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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

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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)

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Division of General, Restorative, and Neurological Devices

510(k) Number K060148

Regulation Number and Section

§ 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.”