CarriCell® is indicated for filling bone voids or defects of the sketal system (i.e., extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. CarriCell® may be hydrated with saline or autologous blood prior to implantation. CarriCell® is a bone graft substitute that resorbs and is replaced with new bone during process.

Device Description

CarriCell® Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of hydration solution to form a putty. No mixing is required. The putty can be administered to the treatment site by syringe or manual application. The material can be shaped into a desired form prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a chemical and crystalline structure similar to that of natural bone minerals. CarriCell® Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a quantifiable table of acceptance criteria with specific numerical targets. Instead, it refers to a guidance document for Class II Special Controls and summarizes the findings.

Acceptance Criteria Category (Implied)	Reported Device Performance
Biocompatibility	Established in accordance with ISO 10993-1.
Material Properties	Crystalline phase analysis, chemical identity, pH, setting temperature, elemental morphology, and mechanical properties tested. (Specific metrics not provided, but implicitly met for equivalence.)
In-vivo Performance (Bone Healing)	In-vivo Study Conclusion: CarriCell® material performed as intended with proper osteointegration with host bone in a femoral core defect model. Demonstrated efficacy as a standalone bone graft substitute.
Sterilization	Gamma Irradiation for an SAL of 10-6.
Pyrogenicity	Non-Pyrogenic per USP <85>.

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

Test Set (In-vivo Study): The document mentions "an in-vivo study was performed as part of the assessment of the subject CarriCell® device" in a "femoral core defect model." It does not specify the sample size (number of animals or defects) used in this study.
Data Provenance: The document states "an in-vivo study was performed." Animal studies are typically prospective in nature. The country of origin of the data is not specified, but given the FDA submission, it would likely be from studies conducted under US or internationally recognized guidelines.

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

The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the in-vivo study. It only states the "study concluded that CarriCell® material did perform as intended with proper osteointegration with host bone." This suggests an assessment by relevant scientific or medical professionals, but specifics are absent.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the in-vivo study. It simply states the study concluded with a positive finding regarding performance and osteointegration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This document describes a submission for a bone graft substitute material, not an AI or imaging device. Therefore, the concepts of human readers, AI assistance, or effect sizes in that context are not applicable.

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

No, a standalone algorithm performance study was not done. As mentioned above, this is for a bone graft substitute, not an AI or software device.

7. The Type of Ground Truth Used

For the in-vivo study, the ground truth would have been established through histological analysis, radiographic imaging, and potentially biomechanical testing performed on the animal models. The conclusion of "proper osteointegration with host bone" implies such biological and structural evidence formed the basis of the assessment.

8. The Sample Size for the Training Set

This question is not applicable as the device is a bone graft substitute material, not a machine learning or AI algorithm that requires a training set. The "testing" refers to non-clinical bench testing and in-vivo animal studies to demonstrate material properties and biological performance.

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

This question is not applicable for the same reason as point 8.

Summary

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Image /page/0/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 an emblem featuring a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 20, 2015

ETEX Corporation Michael Strunk, Ph.D. Director of Research 675 Massachusetts Avenue Cambridge, Massachusetts 02139

Re: K132868

Trade/Device Name: ETEX CarriCell® Bone Substitute Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 22, 2015 Received: January 23, 2015

Dear Dr. Strunk:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Michael Strunk, Ph.D.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K132868

Device Name ETEX CarriCell® Bone Substitute Material

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Submitter:	ETEX Corporation675 Massachusetts AvenueCambridge, MA 02139
Registration No.:	1225112
Owner/Operator No.:	9014709
Contact Person	Michael Strunk PhD

Michael Strunk, PhD. Contact Person: Director of Research Office: (617) 577-0706 Fax: (617) 577-7170 E-Mail: mstrunk@etexcorp.com
Date Prepared: February 17, 2015
MQV (21 CFR $888.3045) Product Code(s):
Device Class: II (21 CFR §888.3045)
Classification Panel: Orthopaedics
Classification Name: Filler, Bone Void, Calcium Compound (21 CFR §888.3045)
Proprietary Name: CarriCell® Bone Substitute Material

Predicate Device(s): EquivaBone® Osteoinductive Bone Graft Substitute cleared per K063050 (ETEX Corporation) CarriGen® Porous Bone Substitute Material cleared per K062630 (ETEX Corporation) PROGENIX® DBM Putty per K060794 (Medtronic Sofamor Danek)

Device Description: CarriCell® Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of hydration solution to form a putty. No mixing is required. The putty can be administered to the treatment site by syringe or manual application. The material can be shaped into a desired form prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a chemical and crystalline structure similar to that of natural bone minerals. CarriCell® Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

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CarriCell® is indicated for filling bone voids or defects of the skeletal Intended Use: system (i.e., extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriCell® may be hydrated with saline or autologous blood prior to implantation. CarriCell® is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Materials: Synthetic calcium phosphate biomaterial, sodium alginate, and sodium carboxymethylcellulose (CMC).
The following table summarizes the specific technological Predicate Comparison: characteristic similarities and differences between CarriCell® and the cited predicate devices.

	CarriCell® BoneSubstituteMaterial	EquivaBone®OsteoinductiveBone GraftSubstitute	CarriGen®Porous BoneSubstituteMaterial	PROGENIX®DBM Putty
K-Number	K132868	K063050	K062630	K060794
Product Code	MQV	MQV	MQV	MQV
Classification	21 CFR §888.3045	21 CFR §888.3045	21 CFR §888.3045	21 CFR §888.3045
Materials	93% CalciumPhosphate5 % CMC2% SodiumAlginate	45% CalciumPhosphate5 % CMCcarboxymethylcellulose50% DBMdemineralized bonematrix	91.5% CalciumPhosphate3.5 % CMC5% EfferSoda™	Demineralizedbone matrix, bovinecollagen, sodiumalginate
Ca:P ratio	$1.22 \pm 0.06$	$1.65 \pm 0.05$	$1.40 \pm 0.02$	N/A
Physical Form	Moldable orInjectable Paste	Moldable Paste	Moldable orInjectable Paste	Injectable DBM inAlginate/CollagenMatrix
ProductDesign	Self-setting calciumphosphate materialwith CMC andsodium alginatethat hardens inaqueousenvironment at 37°C.	Self-setting calciumphosphate materialwith CMC andDemineralizedBone Matrix(DBM) thathardens in aqueousenvironment at37°C.	Self-setting calciumphosphate materialwith CMC andEfferSoda thathardens in aqueousenvironment at37°C.	DemineralizedBone Matrix(DBM) in a sodiumalginate gel carrier.
Kit Sizes	1cc to 20cc	1cc to 20cc	1cc to 20cc	N/A

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Sterilization	Gamma Irradiationfor an SAL of 10-6	Gamma Irradiationfor an SAL of 10-6	Gamma Irradiationfor an SAL of 10-6	N/A
Pyrogenicity	Non-Pyrogenic perUSP <85>	Non-Pyrogenic perUSP <85>	Non-Pyrogenic perUSP <85>	N/A

Testing consistent with Class II Special Controls Guidance Document: Performance Data: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted.

An in-vivo study was performed as part of the assessment of the subject CarriCell® device. This study assessed the performance of the material in a femoral core defect model. The study concluded that CarriCell® material did perform as intended with proper osteointegration with host bone.

Non-clinical in-vitro bench testing included crystalline phase analysis, analysis, chemical identity, pH, setting temperature, elemental morphology, and mechanical properties. Biocompatibility of the device has been established in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and Testing.

Performance data and in-vivo animal studies have demonstrated that CarriCell® is efficacious as a standalone bone graft substitute, mixed with either saline or autologous blood.

The conclusions drawn from the nonclinical and clinical tests demonstrate Conclusions: that the CarriCell® device is as safe, as effective, and performs as well as or better than the predicate device.

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.