Calcigen™-NaP Bone Void Filler is intended for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.

Device Description

Calcigen™-NaP Bone Void Filler is a synthetic, self-setting paste for use as a bone graft substitute. The product is provided in pre-measured quantities of powder and setting solution. The two components are mixed together intra-operatively to form a thick, moldable paste that is then applied to the bone void or defect. The paste can be shaped to completely fill the bone defect and hardens in-situ to prevent migration out the defect area. It is designed to be applied/delivered to the defect either using a spatula or equivalent instrument or injected thru a syringe into open defects. The material is resorbed and replaced by bone during the healing process.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called Calcigen™-NaP Bone Void Filler. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving performance against specific acceptance criteria through clinical studies.

Therefore, the information typically requested regarding acceptance criteria, specific device performance metrics, and detailed study parameters (like sample size for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not present in this document.

Here's a breakdown of why and what information is available:

1. Table of acceptance criteria and reported device performance:

Not Applicable. This document does not establish specific performance acceptance criteria for the Calcigen™-NaP Bone Void Filler as would be required for a novel device or a device seeking to demonstrate a specific clinical outcome. Instead, it claims substantial equivalence to predicate devices, meaning its safety and effectiveness are considered comparable to those already on the market.

2. Sample size used for the test set and the data provenance:

Not Applicable. No clinical test set data is presented. The submission relies on non-clinical testing and comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method for the test set:

Not Applicable. No test set or adjudication method is described.

5. 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 device is a bone void filler, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical bone void filler, not an algorithm or software.

7. The type of ground truth used:

Not Applicable. No ground truth for device performance is explicitly used in the context of this 510(k) submission.

8. The sample size for the training set:

Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

Not Applicable. As above, no training set or ground truth for it exists for this type of device.

What the document does state regarding demonstration of safety and effectiveness:

Non-Clinical Testing: "The information presented demonstrates that the Calcigen™-NaP Bone Void Filler is substantially equivalent to currently marketed predicate devices. The differences between Calcigen™-NaP Bone Void Filler and the predicates are not significant and have already been shown not to present additional safety or efficacy issues."
Clinical Testing: "None is provided as the basis of substantial equivalence." (This explicitly states no clinical trials were done for this submission).
Basis for Substantial Equivalence: "Calcigen™-NaP Bone Void Filler is shown by analysis of available information to be identical in intended use and equivalent in materials and form to currently marketed similar products. The product is identical in chemistry and formulation to 3i® Calcium Sodium Phosphate Bone Cement."

In essence, the "study" demonstrating the device meets "acceptance criteria" (which in this case is substantial equivalence) is a comparison to legally marketed predicate devices through non-clinical testing and analysis of materials, formulation, and intended use. The acceptance criteria are implicitly met by demonstrating that the device is "identical in intended use and equivalent in materials and form" to already cleared devices and that "differences... are not significant and have already been shown not to present additional safety or efficacy issues."

Summary

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K033611

APR 2 7 2004

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510(k) Summary

Applicant/Sponsor:	Biomet Manufacturing Corp.
Contact Person:	Mary L. VerstynenDirector of Clinical Affairs
Proprietary Name:	Calcigen™-NaP Bone Void Filler
Common Name:	Calcium Sodium Phosphate Bone Void Filler
Classification Name:(21 CFR 888.3045)	Resorbable calcium salt bone void filler device

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

· EBI OsteoStim™ Granules Resorbable Bone Graft Substitute (EBI L.P .; K011386)
· α-BSM® Bone Substitute Material (DePuy Orthopaedics, Inc; K011048)
· Pro Osteon® 500R Resorbable Bone Graft Substitute (Interpore Cross; K990131. K980817)
· Norian® SRS® Bone Void Filler (Synthes USA; K011897)
· 3i® Calcium Sodium Phosphate Bone Cement (Biomet, Inc; K003493)

Device Description:

Intended Use:

MAILING ADDRESS Box 587 Box 587 - 3 - 3 - 3 - 3 - - - - - - - - - - - - - - - - - - - - - - - Warsaw, IN 46582

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SHIPPING ADDRESS

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()FFICE 574.267.6639

FAX 574.267.8137

E-MAIL biomet@biomet@biomet.com

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Summary of Technologies:

Calcigen™-NaP Bone Void Filler is shown by analysis of available information to be identical in intended use and equivalent in materials and form to currently marketed similar products. The product is identical in chemistry and formulation to 3i® Calcium Sodium Phosphate Bone Cement.

Non-Clinical Testing:

The information presented demonstrates that the Calcigen™-NaP Bone Void Filler is substantially equivalent to currently marketed predicate devices. The differences between Calcigen™-NaP Bone Void Filler and the predicates are not significant and have already been shown not to present additional safety or efficacy issues.

Clinical Testing:

None is provided as the basis of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

Ms. Mary L. Verstynen Director of Clinical and Regulatory Affairs Biomet Manufacturing Corporation 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K033611

Trade/Device Name: Calcigen™-NaP Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcıum salt bone void filler Regulatory Class: II Product Code: MQV Dated: January 28, 2004 Received: January 30, 2004

Dear Ms. Verstynen:

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 Mcdical 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 (sec 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 he 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. Mary L. Verstynen

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 (301) 594-4659. 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 yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosurc

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Indications for Use

510(k) Number (if known): K033611

Device Name: Calcigen™-NaP Bone Void Filler

Incications For Use:

Calcigen™-NaP Bone Void Filler is intended for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone volds or gaps that are not intrinsic to the structural integrity of the bony structure.

Prescription Use ﻟﺮ (Part 2 1 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

uriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number K033611

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.