(88 days)
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.
ABCcolla® Bone Matrix is a bone mineral matrix of porcine origin. ABCcolla® Bone Matrx is physically and chemically comparable to the mineralized matrix of human bone.
This document (K212156) is a 510(k) premarket notification for a medical device called "ABCcolla® Bone Matrix." It concerns a resorbable calcium salt bone void filler.
Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. The document is for a traditional medical device (bone matrix), not an AI/ML driven device.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study data for an AI/ML device based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate device based on material characteristics, manufacturing processes, and physical specifications.
To answer your request, I would need a document related to an AI/ML medical device and its validation study.
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October 8, 2021
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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
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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
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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)
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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.3rd Fl., No.57, Luke 2nd Rd., Lujhu Dist., Kaohsiung City 82151,TaiwanTelephone: +886-7-6955-569Fax: +886-7-6955-069 |
|---|---|
| Contact Person | DAR-JEN HSIEHCEOE 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, K171629ACRO Biomedical Co., Ltd. |
| Reference Device | · ORTHOSS® Resorbable Bone Void Filler, K090401Ed. Geistlich Soehne Ag Für Chemische Industrie |
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| • Bicera™ Resorbable Bone Substitute, K110949Wiltrom Corporation Limited | ||
|---|---|---|
| • Geistlich Bio-Oss®, K122894Geistlich Pharma Ag | ||
| Device Description | ABCcolla® Bone Matrix is a bone mineral matrix of porcine origin.ABCcolla® Bone Matrx is physically and chemically comparable tothe mineralized matrix of human bone. | |
| Intended Use | ABCcolla® Bone Matrix is an implant intended to fill bony voids ogaps of the skeletal system (i.e., extremities and pelvis). Theseosseous defects are surgically created or the result of traumaticinjury to the bone and are not intrinsic to the stability of the bonystructure. ABCcolla® Bone Matrix resorbs and is replaced withbone during the healing process. | |
| Comparison ofTechnologicalCharacteristics | The subject device is identical to predicate device with respect tomaterials characteristics, manufacturing, sterilization method, andsterile barrier system.Since prior clearance of the device, the only change was to add newproduct specifications for cube or block form. | |
| Characteristic | ABCcolla® Bone Graft(K171629) | ABCcolla® Bone Matrix(subject device) |
| Intended Use | ABCcolla® Bone Graft is animplant intended to fill bonyvoids or gaps of the skeletalsystem (i.e., extremities andpelvis). These osseous defectsare surgically created or theresult of traumatic injury tothe bone and are not intrinsicto the stability of the bonystructure. | ABCcolla® Bone Matrix is animplant intended to fill bonyvoids or gaps of the skeletalsystem (i.e., extremities andpelvis). These osseous defectsare surgically created or theresult of traumatic injury tothe bone and are not intrinsicto the stability of the bonystructure. |
| Graft resorbs and is replacedwith bone during the healingprocess. | Matrix resorbs and isreplaced with bone during thehealing process. | |
| Physical characteristics | ||
| Form | Granule and Cube | Granule and Block |
| Specifications | Maximum volume 5 c.c. | Maximum volume 5 c.c. |
| Manufacture | ||
| Manufacturingconditions | Same manufacturingconditions | Same manufacturingconditions |
| 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 |
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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
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substantially equivalent to the predicate device, ABCcolla® Bone Graft (K171629).
§ 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.