(244 days)
No
The summary describes a bone graft material and its physical, chemical, and biological properties, with no mention of AI or ML.
Yes
The device is described as an "implant intended to fill bony voids or gaps of the skeletal system" and "resorbs and is replaced with bone during the healing process," indicating its therapeutic purpose in aiding bone regeneration and healing.
No
Explanation: The device is an implantable bone graft intended to fill bony voids or gaps, not to diagnose a medical condition.
No
The device description clearly states it is a bone mineral matrix of porcine origin, which is a physical material, not software. The performance studies also focus on material properties and biological interactions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ABCcolla® Bone Graft is an implant intended to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural function within the body.
- Device Description: The description details a bone mineral matrix for implantation.
- Performance Studies: The performance studies focus on properties relevant to an implantable device, such as chemical composition, physical properties, biocompatibility, sterilization, and pre-clinical animal performance testing for bone formation and healing.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The description of ABCcolla® Bone Graft and its intended use do not align with this definition.
N/A
Intended Use / Indications for Use
ABCcolla® Bone Graft is an implant intended to fill bony voids or gaps of the 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 the bony structure. ABCcolla® Bone Graft resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MOV, MQV
Device Description
ABCcolla® Bone Graft is a bone mineral matrix of porcine origin. ABCcolla® Bone Graft is physically and chemically comparable to the mineralized matrix of human bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., extremities and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of ABCcolla® Bone Graft, including chemical composition, physical properties, biocompatibility, sterilization, packing, shelf-life, pyrogenicity and pre-clinical animal performance testing were performed to demonstrate substantial equivalence to the predicate devices.
Chemical composition (hydroxyapatite, Ca/P ratio) was analyzed via X-ray diffraction (XRD), trace element analysis was performed by inductively coupled plasma/mass spectroscopy (ICP/ MS), particle pore size and morphology was evaluated via scanning electron microscopy (SEM), porosity was determined by mercury intrusion porosimetry, density was evaluated via tap density analyzer, and moisture content was determined by moisture analyzer.
Biocompatibility studies were performed in accordance with ISO 10993-1, ISO10993-3, ISO10993-4, ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO10993-11. ABCcolla® Bone Graft was sterilized by gamma-irradiation and the process was validated in accordance with ISO 11137. ABCcolla® Bone Graft also has been tested for its packing integrity. The product shelf-life was evaluated in real-time aging study with passing results. Pyrogenicity was assessed with limulus amebocyte lysate (LAL) method and met the limits of established guidelines.
According to Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device, critical-size bone defect model was performed to evaluated the new bone formation and healing effect of ABCcolla® Bone Graft in pre-clinical animal performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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February 1, 2018
ACRO Biomedical Co., Ltd. Dar-Jen Hsieh Chief Executive Officer 3F, No. 57, Luke 2nd Road, Lujhu District Kaohsiung City 82151 TAIWAN
Re: K171629
Trade/Device Name: ABCcolla® Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: January 10, 2018 Received: January 10, 2018
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. 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
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -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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Indications for Use Statement
510(K) Number (If Known): __K171629
Device Name: ABCcolla® Bone Graft
Indications for Use: ABCcolla® Bone Graft is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and These osseous defects are surgically created or the pelvis). result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ABCcolla® Bone Graft resorbs and is replaced with 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 | |
| Taiwan | |
| Telephone: +886-7-6955-569 | |
| Fax: +886-7-6955-069 | |
| Contact Person | DAR-JEN HSIEH |
| CEO | |
| E mail: dj@acrobiomedical.com | |
| Date of Summary | May 1st, 2017 |
| Name of Device | ABCcolla® Bone Graft |
| Common Name | Resorbable Bone Void Filler |
| Classification | Class II |
| Regulation Number | 21 CFR 888.3045 |
| Product Code | MQV |
| Advisory Panel | ORTHOPEDIC DEVICES |
| Predicate Device | • ORTHOSS® Resorbable Bone Void Filler, K090401 |
| Ed. Geistlich Soehne Ag Für Chemische Industrie | |
| • Bicera™ Resorbable Bone Substitute, K110949 | |
| Wiltrom Corporation Limited | |
| Reference Device | · Geistlich Bio-Oss®, K122894 |
| Geistlich Pharma Ag | |
| Device Description | ABCcolla® Bone Graft is a bone mineral matrix of porcine origin. |
| ABCcolla® Bone Graft is physically and chemically comparable to | |
| the mineralized matrix of human bone. | |
| Intended Use | ABCcolla® Bone Graft is an implant intended to fill bony voids or |
| gaps of the 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 the bony | |
| structure. ABCcolla® Bone Graft resorbs and is replaced with bone | |
| during the healing process. | |
| Technological | ABCcolla® Bone Graft has been designed and manufactured to be |
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Characteristics substantially equivalent to predicate and reference device through comparison in areas including intended use, material origin, physical structure, chemical characteristics (hydroxyapatite, Ca/P ratio), principles of operation and design (user, how supplied, single use, gamma-irradiation sterilization).
ABCcolla® Bone Graft was designed in granule and cube shape similar to the predicate and reference device with different particle size which is between in the maximum and minimum size of the predicate device.
The performance of ABCcolla® Bone Graft, including chemical Performance Data composition, physical properties, biocompatibility, sterilization, packing, shelf-life, pyrogenicity and pre-clinical animal performance testing were performed to demonstrate substantial equivalence to the predicate devices.
Chemical composition (hydroxyapatite, Ca/P ratio) was analyzed via X-ray diffraction (XRD), trace element analysis was performed by inductively coupled plasma/mass spectroscopy (ICP/ MS), particle pore size and morphology was evaluated via scanning
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electron microscopy (SEM), porosity was determined by mercury intrusion porosimetry, density was evaluated via tap density analyzer, and moisture content was determined by moisture analyzer.
Biocompatibility studies were performed in accordance with ISO 10993-1, ISO10993-3, ISO10993-4, ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO10993-11. ABCcolla® Bone Graft was sterilized by gamma-irradiation and the process was validated in accordance with ISO 11137. ABCcolla® Bone Graft also has been tested for its packing integrity. The product shelf-life was evaluated in real-time aging study with passing results. Pyrogenicity was assessed with limulus amebocyte lysate (LAL) method and met the limits of established guidelines.
According to Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device, critical-size bone defect model was performed to evaluated the new bone formation and healing effect of ABCcolla® Bone Graft in pre-clinical animal performance testing.
Substantial ABCcolla® Bone Graft is substantially equivalent to the predicate Equivalence device with respect to functionality, design, materials, sterilized Summary method, package material, intended use and performance characteristics.
Conclusion Based on the 510(k) summaries and the information provided herein, we conclude that ABCcolla® Bone Graft is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act.