CARRICELL

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) 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. 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." {3}------------------------------------------------ ## 510(k) Summary | Submitter: | ETEX Corporation<br>675 Massachusetts Avenue<br>Cambridge, 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. {4}------------------------------------------------ - 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® Bone<br>Substitute<br>Material | EquivaBone®<br>Osteoinductive<br>Bone Graft<br>Substitute | CarriGen®<br>Porous Bone<br>Substitute<br>Material | PROGENIX®<br>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% Calcium<br>Phosphate<br>5 % CMC<br>2% Sodium<br>Alginate | 45% Calcium<br>Phosphate<br>5 % CMC<br>carboxymethyl<br>cellulose<br>50% DBM<br>demineralized bone<br>matrix | 91.5% Calcium<br>Phosphate<br>3.5 % CMC<br>5% EfferSoda™ | Demineralized<br>bone matrix, bovine<br>collagen, sodium<br>alginate | | Ca:P ratio | $1.22 \pm 0.06$ | $1.65 \pm 0.05$ | $1.40 \pm 0.02$ | N/A | | Physical Form | Moldable or<br>Injectable Paste | Moldable Paste | Moldable or<br>Injectable Paste | Injectable DBM in<br>Alginate/Collagen<br>Matrix | | Product<br>Design | Self-setting calcium<br>phosphate material<br>with CMC and<br>sodium alginate<br>that hardens in<br>aqueous<br>environment at 37°<br>C. | Self-setting calcium<br>phosphate material<br>with CMC and<br>Demineralized<br>Bone Matrix<br>(DBM) that<br>hardens in aqueous<br>environment at<br>37°C. | Self-setting calcium<br>phosphate material<br>with CMC and<br>EfferSoda that<br>hardens in aqueous<br>environment at<br>37°C. | Demineralized<br>Bone Matrix<br>(DBM) in a sodium<br>alginate gel carrier. | | Kit Sizes | 1cc to 20cc | 1cc to 20cc | 1cc to 20cc | N/A | {5}------------------------------------------------ | Sterilization | Gamma Irradiation<br>for an SAL of 10-6 | Gamma Irradiation<br>for an SAL of 10-6 | Gamma Irradiation<br>for an SAL of 10-6 | N/A | |---------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|-----| | Pyrogenicity | Non-Pyrogenic per<br>USP <85> | Non-Pyrogenic per<br>USP <85> | Non-Pyrogenic per<br>USP <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.