ABCcolla Bone Matrix

{0}------------------------------------------------ October 8, 2021 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. ACRO Biomedical Co., Ltd. Dar-Jen Hsieh, CEO 3rd Fl., No. 57, Luke 2nd Rd., Lujhu Dist. Kaohsiung City, 82151 Taiwan Re: K212156 Trade/Device Name: ABCcolla® Bone Matrix Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 12, 2021 Received: July 12, 2021 Dear Dar-Jen Hsieh: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for ACRO Biomedical Co., Ltd. The logo features a stylized cross in gray and red with a green leaf on top. To the right of the cross is the company name, "ACRO Biomedical Co., Ltd.", with a line underneath. ## Indications for Use Statement 510(K) Number (If Known): Device Name: ABCcolla® Bone Matrix Indications for Use: ABCcolla® Bone Matrix is intended to fill bony voids or gaps of skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of bone structure. ABCcolla® Bone Matrix provides resorbs and is replaced by bone during the healing process. Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for ACRO Biomedical Co., Ltd. The logo features a stylized cross symbol in red and gray, with a green leaf element incorporated into the design. The text "ACRO Biomedical Co., Ltd." is positioned to the right of the cross symbol in a light gray font. ## 510(k) Summary This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR 807.92. The assigned 510(k) number is_________________________________________________________________________________________________________________________________________________ | Applicant | ACRO Biomedical Co., Ltd.<br>3rd Fl., No.57, Luke 2nd Rd., Lujhu Dist., Kaohsiung City 82151,<br>Taiwan<br>Telephone: +886-7-6955-569<br>Fax: +886-7-6955-069 | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | DAR-JEN HSIEH<br>CEO<br>E mail: dj@acrobiomedical.com | | Date of Summary | June 1st, 2021 | | Name of Device | ABCcolla® Bone Matrix | | Common Name | Resorbable Bone Void Filler | | Classification | Class II | | Regulation Number | 21 CFR 888.3045 | | Product Code | MQV | | Advisory Panel | ORTHOPEDIC DEVICES | | Predicate Device | · ABCcolla® Bone Graft, K171629<br>ACRO Biomedical Co., Ltd. | | Reference Device | · ORTHOSS® Resorbable Bone Void Filler, K090401<br>Ed. Geistlich Soehne Ag Für Chemische Industrie | {4}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | • Bicera™ Resorbable Bone Substitute, K110949<br>Wiltrom Corporation Limited | | | |------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | • Geistlich Bio-Oss®, K122894<br>Geistlich Pharma Ag | | | | Device Description | ABCcolla® Bone Matrix is a bone mineral matrix of porcine origin.<br>ABCcolla® Bone Matrx is physically and chemically comparable to<br>the mineralized matrix of human bone. | | | Intended Use | ABCcolla® Bone Matrix is an implant intended to fill bony voids o<br>gaps of the skeletal system (i.e., extremities and pelvis). These<br>osseous defects are surgically created or the result of traumatic<br>injury to the bone and are not intrinsic to the stability of the bony<br>structure. ABCcolla® Bone Matrix resorbs and is replaced with<br>bone during the healing process. | | | Comparison of<br>Technological<br>Characteristics | The subject device is identical to predicate device with respect to<br>materials characteristics, manufacturing, sterilization method, and<br>sterile barrier system.<br>Since prior clearance of the device, the only change was to add new<br>product specifications for cube or block form. | | | Characteristic | ABCcolla® Bone Graft<br>(K171629) | ABCcolla® Bone Matrix<br>(subject device) | | Intended Use | ABCcolla® Bone Graft is an<br>implant intended to fill bony<br>voids or gaps of the skeletal<br>system (i.e., extremities and<br>pelvis). These osseous defects<br>are surgically created or the<br>result of traumatic injury to<br>the bone and are not intrinsic<br>to the stability of the bony<br>structure. | ABCcolla® Bone Matrix is an<br>implant intended to fill bony<br>voids or gaps of the skeletal<br>system (i.e., extremities and<br>pelvis). These osseous defects<br>are surgically created or the<br>result of traumatic injury to<br>the bone and are not intrinsic<br>to the stability of the bony<br>structure. | | | Graft resorbs and is replaced<br>with bone during the healing<br>process. | Matrix resorbs and is<br>replaced with bone during the<br>healing process. | | Physical characteristics | | | | Form | Granule and Cube | Granule and Block | | Specifications | Maximum volume 5 c.c. | Maximum volume 5 c.c. | | Manufacture | | | | Manufacturing<br>conditions | Same manufacturing<br>conditions | Same manufacturing<br>conditions | | Viral inactivation | Same viral inactivation step | Same viral inactivation step | | Sterilization | Gamma radiation | Gamma radiation | | Packaging | Glass bottle and Tyvek pouch | Glass bottle and Tyvek pouch | {5}------------------------------------------------ The subject device is made of the same raw materials and Substantial manufactured with the same manufacturing process (except for Equivalence cutting the bone material in different length and/or height to Summary generate the new specifications), hence the material properties are identical. > Further, the same release testing as performed for the predicate is conducted for the subject device and includes determination of appearance, specification (granule size, weight, or dimension), moisture content and sterility test. The predicate and subject devices are also tested according to USP<85> and USP<161>. and the devices are met the endotoxin acceptance limit of 20 EU/device. The only difference between the subject device and predicate device is the dimension of the cube/block form products. These new product specifications are all within the range of product volume previously cleared for the predicate device, and the lot tests have been done that confirm that the dimension change does not affect the final product and that, as such, it is substantially equivalent to the previously cleared predicate device. - Based on the 510(k) summaries and the information provided Conclusion herein, it can be concluded that ABCcolla® Bone Matrix is {6}------------------------------------------------ Image /page/6/Picture/0 description: The image features the logo of ACRO Biomedical Co., Ltd. The logo consists of a stylized cross symbol in gray and red, with a green leaf element incorporated into the design. The text "ACRO Biomedical Co., Ltd." is positioned to the right of the cross symbol, with the company name underlined. substantially equivalent to the predicate device, ABCcolla® Bone Graft (K171629).