(124 days)
Not Found
No
The summary describes a bone void filler made of bioactive glass fibers and does not mention any computational or analytical functions that would involve AI or ML.
No.
The device is a bone void filler that resorbs and is replaced with bone during healing, rather than actively treating an underlying condition or disease.
No
The device is a bone void filler intended for surgical implantation to aid in bone healing, not for diagnosing medical conditions.
No
The device description clearly states the device is a physical implant made from bioactive glass in the shape of cylinders, blocks, and wedges, intended for use as a bone void filler. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "bone void filler" for "bony voids or gaps of the skeletal system." This describes a device that is implanted into the body to aid in bone healing.
- Device Description: The description reinforces this by detailing the physical form (cylinders, blocks, wedges), material (bioactive glass), and mechanism of action (resorption and replacement with bone).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The information provided describes a medical device used for surgical implantation, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Bio2 CLM-BG Bioactive Scaffold is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bioactive Scaffold is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV, OIS
Device Description
The Bio2 Technologies implants are bone void fillers in the shape of cylinders, blocks and wedges. The devices are osteoconductive, bioactive, bone void fillers. The implants are made from a fiber based bioactive glass. The material can be drilled and tapped, and screws can be placed through it. The device structure allows tissue infiltration between the bioactive glass fibers. The fibers then are slowly absorbed and replaced by new bone tissue during the healing process. The cylinders, blocks and wedges are provided sterile and are intended for single use.
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)
Biocompatibility of the device has been established according to blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing," In vitro bioactivity testing (ISO 23317:2012) shows the material forms a surface apatite layer when submerged in simulated body fluid.
In vivo animal studies show the device achieves bony healing in a critical defect model, confirmed with radiographs, histology and histomorphometry.
In vivo tests have demonstrated bone formation at each post-implantation time point. In the study critical size defects were filled with Bio2 CLM • B Bioactive Scaffold and the control material. The rabbit femurs were evaluated at 8 and 16 weeks using x-ray, histology, histomorphometry, SEM and EDX. The Bio2 CLM•BG Bioactive Scaffold was shown to be as safe and effective as the control material.
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.
Bio2 Technologies, Bio2 CLM•BG Bioactive Scaffold K142463, Synthes chronOS K013072, Norian Drillable Bone Void Filler and Norian Drillable Fast Set Putty K073303
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.
Not Found
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.
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Bio2 Technologies, Incorporated Janet Krevolin, Ph.D. Chief Technical Officer 12-R Cabot Road Woburn, Massachusetts 01801
January 12, 2016
Re: K152589
Trade/Device Name: Bio2 CLM.BG Bioactive Scaffold Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, OIS Dated: November 30, 2015 Received: December 03, 2015
Dear Dr. Krevolin:
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
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/ResourcesforYou/Industry/default.htm. 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.
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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K152589
Device Name Bio2 CLM.BG Bioactive Scaffold
Indications for Use (Describe)
The Bio2 CLM-BG Bioactive Scaffold is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bioactive Scaffold is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
The product provides a bone void filler that resorbs and is replaced with bone during the healing 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."
FORM FDA 3881 (1/14)
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510(k) Summary
Summary of 510(k) safety and effectiveness information upon which the substantial equivalence determination is based:
I. Submitter
| Date Prepared:
Device Submitter: | November 20, 2015
Bio2 Technologies
12-R Cabot Road
Woburn, MA 01801 |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | 781-721-6309 |
| Contact Person: | Janet Krevolin, PhD |
| Device
II. | |
| Device Name:
Common Name:
Classification Name: | Bio2 CLM•BG Bioactive Scaffold
Bone void filler
Resorbable calcium salt bone void filler device (21
CFR 888.3045) |
| Regulatory Class:
Product Code: | II
MOV, OIS |
| III.
Predicate Device | |
| Predicate Device: | Bio2 Technologies, Bio2 CLM•BG Bioactive Scaffold
K142463
Synthes chronOS K013072
Norian Drillable Bone Void Filler and Norian |
IV. Device Description
The Bio2 Technologies implants are bone void fillers in the shape of cylinders, blocks and wedges. The devices are osteoconductive, bioactive, bone void fillers. The implants are made from a fiber based bioactive glass. The material can be drilled and tapped, and screws can be placed through it. The device structure allows tissue infiltration between the bioactive glass fibers. The fibers then are slowly absorbed and replaced by new bone tissue during the healing process. The cylinders, blocks and wedges are provided sterile and are intended for single use.
Drillable Fast Set Putty K073303
V. Indications for Use
The Bio2 CLM•BG Bioactive Scaffold is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bio2 CLM•BG Bioactive
4
Scaffold is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects mav be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
- VI. Comparison of technological characteristics with the predicate device
Bio2 CLM.BG Bioactive Scaffold is an osteoconductive, bioactive bone graft device. The Bio2 CLM•BG Bioactive Scaffold complies with the requirements of ASTM F-1538. In vitro testing confirms the formation of a hydroxvapatite laver on the surface of the implant when immersed in simulated body fluid. In vivo tests have demonstrated bone formation at each post-implantation time point. In the study critical size defects were filled with Bio2 CLM • B Bioactive Scaffold and the control material. The rabbit femurs were evaluated at 8 and 16 weeks using x-ray, histology, histomorphometry, SEM and EDX. The Bio2 CLM•BG Bioactive Scaffold was shown to be as safe and effective as the control material.
Bio2 CLM.BG Bioactive Scaffold consists of different size cvlinders, blocks and wedges made of degradable and resorbable bioactive glass. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate laver that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing repair of the defect. The material is radiopaque. Bio2 CLM•BG Bioactive Scaffold implants are intended for single use and are provided sterile to the user. They are completely synthetic and non-collagenous.
- VII. Performance Data
Biocompatibility of the device has been established according to blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing," In vitro bioactivity testing (ISO 23317:2012) shows the material forms a surface apatite layer when submerged in simulated body fluid.
In vivo animal studies show the device achieves bony healing in a critical defect model, confirmed with radiographs, histology and histomorphometry.
- VIII. Conclusions
The Bio2 CLM•BG Bioactive Scaffold when compared to the predicates have the same intended use and same indications, technological characteristics, and principals of operation as its predicate device. In vivo test data demonstrates that the Bio2 CLM.BG Bioactive Scaffold is as safe and effective as the predicate devices. Thus the Bio2 CLM+BG Bioactive Scaffold is substantially equivalent to the predicate.