Norian CRS is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2.

Device Description

Norian Craniofacial Repair System (Norian CRS) is a paste-like bone cement which is intended for the restoration or augmentation of bony contours in the craniofacial skeleton, such as burr hole voids and other cranial defects. Norian CRS is an injectable and moldable, biocompatible, bone coment. The Norian CRS Reactants Pack contains the two sterile components used in Norian CRS: Calcium Phosphate Powder and Sodium Phosphate Solution.

When the Reactants Pack is mixed, a smooth, viscous paste is applied directly to the opcrative site, where it hardens in about 10 minutes to provide initial structural support. Within 24 hours, Norian CRS cures into a carbonated apatie that is similar to the mincral component of bone. The compresssive strength of Norian CRS is approximately 50MPa. Over time, Norian CRS is gradually resorbed.

The Norian Mixer. Delivery Device, and Delivery Needles are used to mix and deliver the Norjan CRS to the operative site.

AI/ML Overview

This document describes the Norian CRS (Craniofacial Repair System), a bone cement intended for filling craniofacial defects. The information provided outlines its technological characteristics, performance data, and regulatory approval.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Metric)	Reported Device Performance
X-ray Diffraction - Setting Time	Set (initial hardening) occurs at about 10 minutes.
X-ray Diffraction - Reaction Completion	Reaction is greater than 90% complete by 24 hours.
X-ray Diffraction - Cured Material Composition	Cures to become an apatite of low crystalline order with no by-products present.
pH Value Determination - pH Range	pH range of Norian CRS is 6.0-8.0 (measured during and after setting).
Dimensional Verification - Dimensional Change	No significant dimensional changes (<1%) at body temperature (37°C), determined by comparing mold dimensions with Norian CRS samples.
Solubility Testing	Solubility and solubility products were found to be equivalent to the predicate device (Osteogenics BoneSource® Hydroxyapatite Cement).
Porosity Testing	Average percent porosity was found to be equivalent to the predicate device. Both materials resulted in microporous structures of polycrystalline apatite.
Biocompatibility Testing - (General)	Passed all tests, showed no toxic, mutagenic, or irritating effect. Deemed acceptable for its intended use as a bone implant material.
Sterilization - Method & Standard Compliance	Gamma radiation, following ANSI/AAMI ST32-1992, Method 3A/3B. The Reactants Pack is sterile and for single use.
Compressive Strength	Approximately 50MPa (mentioned in Device Description, not framed as a "test" but a characteristic). While not explicitly an "acceptance criterion" in the performance data section, it's a critical performance characteristic presented. For the purpose of this table, it's included as a desired performance trait the device exhibits.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample sizes used for any of the in vitro tests (X-ray diffraction, pH, dimensional verification, solubility, porosity, biocompatibility).

The data provenance is in vitro testing as explicitly stated in the "Performance Data" section. There is no mention of human subject data, animal studies (beyond general "biocompatibility testing" which is typically done in vitro first, then potentially in vivo, but the document only mentions "passed all tests" without detailing the nature of those tests), or retrospective/prospective studies in a clinical context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the provided document. The studies described are in vitro laboratory tests to determine physical and chemical properties of the bone cement. There is no mention of subjective assessments by experts requiring ground truth establishment in this context.

4. Adjudication Method for the Test Set

This information is not applicable. As the studies are in vitro laboratory tests measuring objective physical and chemical properties, there is no need for adjudication methods typically used in subjective expert assessments or clinical trials.

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

This information is not applicable. The device is a bone cement, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical bone cement, not a standalone algorithm.

7. The Type of Ground Truth Used

For the in vitro performance tests, the "ground truth" is largely based on standard scientific measurement techniques and established material science principles. For example:

X-ray Diffraction: The patterns and intensity of diffracted X-rays directly reveal crystallographic structure and phase composition.
pH Value Determination: Direct measurement using a pH meter.
Dimensional Verification: Direct measurement of dimensions.
Solubility and Porosity Testing: Standard laboratory techniques for these material properties.
Biocompatibility Testing: Compliance with recognized international standards for biocompatibility (e.g., ISO 10993 series), which involves specific in vitro and/or in vivo tests to assess cytotoxicity, irritation, sensitization, etc. The document mentions "Good Laboratory Practice regulation" and that tests "passed all tests."

The primary "ground truth" for the device's overall substantial equivalence is its comparison to the predicate device, Osteogenics BoneSource® Hydroxyapatite Cement. The document asserts equivalence based on similar material properties and behavior.

8. The Sample Size for the Training Set

This information is not applicable. The Norian CRS is a physical medical device (bone cement), not a machine learning model or algorithm that requires a training set in the computational sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As explained above, there is no training set for this type of device.

Summary

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MAY 1 5 1998 510(k) Summary

K973789

General Information

Bone Cement Classification Name:

Hydroxyapatite Cement (HAC) Common Name:

Norian CRSTM Device Trade Name:

Classification Code:

Submitter's Name & Address: Norian Corporation

10260 Bubb Road

Cuperino, CA 95014-4166

(408)252-6800

Establishment Registration:

Contact Person: Susan G. Marques, Manager, Regulatory Affairs Summary Preparation Date: May 14, 1998

Predicate Device

Norian CRSTM is substantially equivalent to Osteogenics BoneSource® Hydroxyapatite Cement (K933339, K964537. K970400).

Device Description

The Norian Mixer. Delivery Device, and Delivery Needles are used to mix and deliver the Norjan CRS to the operative site.

Indications for Use

Norian CRS is intended for filling craniofacial defects in the restoration of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2.

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Technological Characteristics

Norian CRS is comprised of monocalcium phosphate, inonohydrate (MCPM, Ca(H,PO2)x+H2O], & - iricalcium phosphate (TCP, Ca3(PO2)}], and calcium carbonate (CC,CaCO,) to which a sodium phosphate solution is added to form a paste. The paste cures in situ at 37°C for approximately 12 hours, Norian CRS cures into a carbonated aparite that is similar to the mineral component of bone.

Performance Data

The following summaries present the results of Norian CRS in vitro testing:

X-ray Diffraction

The x-ray diffraction data demonstrates that sct (initial hardening) occurs at about 10 minutes, and the reaction is greater than 90% complete by 24 hours. In addition, the x-ray diffraction patterns demonstrate that Norian CRS cures to become an apatite of low crystalline order with no by-products present.

DH Value Determination

Laboratory testing showed that the pH range of Norian SRS is 6.0-8.0. The testing measured the pH values both during and after setting.

Dimensional Verification

Norian SRS hardens in approximately 10 minutes at body temperature (37°C) with no significant dimensional changes (<1%) as determined by comparing the dimensions of molds with the dimensions of Norian CRS samples prepared from the same molds.

Solubility Testing

The solubility and solubility products of Norian CRS were found to be equivalent to the prodicate device.

Porosity Testing

The average percent porosity of Norian CRS was found to the predicate device. Both materials resulted in microporous structures of polycrystalline apatite.

Biocompatibility Testing

Biocompatibility testing was conducted and performed in compliance with the Good Laboratory Practice regulation to evaluate Norian SRS passed all tests, and showed no toxic, muragenic or irritating effect. The test data showed that Norian SRS is acceptable for its intended use as a bone implant material.

Sterilization

The Norian CRS Reactants Pack is provided sterile and is for single use only. Sterlization is conducted using gamma radiation, following ANSVAAMI ST32-1992, Method 3A/3B.

Substantial Equivalence

Notian CRSTM is substantially equivalent to Ostcogenics BoncSource® Hydroxyapatite Cement (KSS3339, K964537, K970400). Like the predicate device, Norian CRS is a bone cement which hardens in situ to augment or restore bony contours in the craniofacial skeleton. Any minor differences between Norian CRS and the predicate device do not raise new questions of safety or effectiveness.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY | 8 1998

Ms. Susan Marques Manager, Regulatory Affairs Norian Corporation 10260 Bubb Road Cupertino, California 95014-4166

Re : K973789 Norian® CRS™ Craniofacial Repair System Requlatory Class: II Product Code: GXP Dated: February 13, 1998 Received: February 17, 1998

Dear Ms. Marques:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device identified in your submission is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Susan Marques

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Celia M. Witten. Ph.D., M.

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

Enclosure

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510(k) Number (if known): K973789

Norian Craniofacial Repair System (CRS®) Bone Cement Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE • CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

Over-the-Counter Use __

(Optional Format 1-2-96)

eolca

(Division Sign-Off)
Division of General Restorative Devices K973781
510(k) Number

Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).