(98 days)
Not Found
No
The summary describes a bone grafting material made of bioactive glass and its performance in preclinical and clinical studies. There is no mention of AI or ML technology being used in the device itself or in its operation.
No.
A therapeutic device is one that treats or cures a disease or condition. This device is intended for augmentation or reconstruction, which is restorative rather than therapeutic.
No
The device, BonAlive™ products, is described as a sterile medical device made of S53P4 bioactive glass intended for the augmentation or reconstruction of the cranio-maxillofacial skeleton, specifically for filling defects and replacing damaged bony tissue, which indicates a therapeutic or reconstructive function rather than a diagnostic one.
No
The device is described as sterile medical devices made of bioactive glass, supplied as granules and plates, which are physical materials intended for surgical implantation. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "augmentation or reconstruction of the cranio-maxillofacial skeleton." This describes a surgical implant used directly in the body for structural support and bone regeneration.
- Device Description: The description details a sterile medical device made of bioactive glass, designed to bond with living tissue and promote bone formation. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or treatment. The device itself is implanted into the body.
Therefore, BonAlive™ Granules and BonAlive™ Plate are classified as medical devices, specifically surgical implants for bone grafting, not IVDs.
N/A
Intended Use / Indications for Use
BonAlive™ Granules and BonAlive™ Plate are intended for the augmentation or reconstruction of the cranio-maxillofacial skeleton.
Product codes (comma separated list FDA assigned to the subject device)
KKY
Device Description
BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to guide tissue growth, bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive and bacterialgrowth inhibiting material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P>O5 4%. BonAlive™ products are supplied as granules and plates. Both are bone grafting materials intended to fill, augment, or reconstruct bony defects of the cranial and maxillofacial region. BonAlive™ granules and plates are sterilized in hot dry air. The granules are available as different granule and unit sizes. The plates are available in different shapes and sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranio-maxillofacial skeleton
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)
Preclinical testing included biocompatibility, solubility, surface structure and dissolution. The amounts of Si and P released from BAG were extremely low indicating a good stability and safety of this material for clinical use in frontal sinus obliteration gThe amount of calcium (Ca) released from the material seems to create a suitable environment for formation of calcium phosphate layer that is prerequisite for new bone formation. The biocompatibility tests showed the device was safe for the intended uses.
In animal studies BAG produced more and faster new bone than did the hydroxyl apatite that was used as a control. Proper blood circulation in the periosted in flap at early stage predisposed the healing process with both materials. The healing process proceeded after the connective tissue phase to obliteration of bone cavity both in animal and in human clinical studies.
Clinically BAG is well functioning, stable, safe and well tolerated glass material that creates suitable local environment for permanent filling of frontal sinuses. Remnants of glass particles found in the bony filling seem to maintain the achieved bone formation and closure of sinuses. The healing process and stability of the clinical outcome in sinuses could be assessed reliably by using the ROI assessments.
In patients with orbital floor fractures the orbital floor prostheses manufactured from BAG have been well functioning and well tolerated. The same conclusion can be made on the use of BAG in septum perforations and narrowing of the nasal cavity. The material itself has not caused any harmful reactions during the clinical follow-up period.
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.
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
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "Vivoxid" in a stylized font. The letters are in black, with the first three letters being solid and the last four letters having a textured, almost pixelated appearance. The font appears to be a serif font.
510(k) Summary
CCT 1 9 2007
Submitter: Vivoxid Ltd. Turku, Finland
Contact Information: Constance G. Bundy C. G. Bundy Associates, Inc. 6470 Riverview Terrace Fridley, MN 55432
Submission Date: July 10, 2007
Device Name and Classification: BonAlive™ Granules and Plates
Image /page/0/Figure/8 description: The image shows the text "Product Code: KKY" and "Class II per 21 CFR 878.3500". The text is black and is on a white background. The image is a close-up of the text.
Equivalent Device Identification: Porous HDPE Surgical Implants, K022665 PerioGlas® Bone Graft Particulate, K053387
Device Description: BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to guide tissue growth, bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive and bacterialgrowth inhibiting material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P>O5 4%. BonAlive™ products are supplied as granules and plates. Both are bone grafting materials intended to fill, augment, or reconstruct bony defects of the cranial and maxillofacial region. BonAlive™ granules and plates are sterilized in hot dry air. The granules are available as different granule and unit sizes. The plates are available in different shapes and sizes.
Intended Use: BonAlive™ Granules and BonAlive™ Plate are intended for the augmentation or reconstruction of the cranio-maxillofacial skeleton.
Vivoxid Ltd. Turku, Finland
1
Image /page/1/Picture/0 description: The image shows the word "Vivoxid" in a stylized font. The first two letters, "Vi", are in a clear, bold font, while the rest of the letters appear to be textured or slightly blurred. The word is presented in a simple, straightforward manner against a plain background.
Comparison Table:
| Descriptive
Information | BonAlive™ granules and
plates | Porous HDPE
Surgical
Implants, K022665 | PerioGlas Bone
Graft Particulate,
K053387 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Intended Use | BonAlive™ Granules and
BonAlive™ Plate are
intended for the
augmentation or
reconstruction of the cranio-
maxillofacial skeleton. | Porous HDPE
Surgical Implants
are intended
for the augmentation
or reconstruction
of the cranio-
maxillofacial areas. | Same as BonAlive
device |
| Material and
properties | S53P4 Bioactive Glass -
synthetic, osteoconductive,
bacterial growth inhibiting | Alloplastic, porous
high density
polyethylene
(HDPE) | 45S5 Bioactive
Glass - same
properties as
BonAlive |
| Product Form | Granules and plates | Block, sheet,
anatomical shapes | Particulates |
| Mode of Action | Tissue bonds to the
bioactive glass due to the
formation of a silica-gel
layer on the glass. The
silica-rich layer acts as a
template for a calcium
phosphate precipitation,
which bonds the bioactive
glass to the surrounding
bone. | The porous HDPE
allows for bony
tissue ingrowth into
its pores | Same as BonAlive
device |
| Resorption Rate | Slowly, over a period of
years | Not applicable | Six months |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Sterilization Method | Hot dry air | Sterile | EtO |
Summary of Perfomance Testing of Bioactive Glass (BAG) S53P4, BonAlive™:
Preclinical testing included biocompatibility, solubility, surface structure and dissolution. The amounts of Si and P released from BAG were extremely low indicating a good stability and safety of this material for clinical use in frontal sinus obliteration gThe amount of calcium (Ca) released from the material seems to create a suitable environment for formation of calcium phosphate layer that is prerequisite for new bone formation. The biocompatibility tests showed the device was safe for the intended uses.
In animal studies BAG produced more and faster new bone than did the hydroxyl apatite that was used as a control. Proper blood circulation in the periosted in flap at early stage predisposed the healing process with both materials. The healing process proceeded after the connective tissue phase to obliteration of bone cavity both in animal and in human clinical studies.
2
VivoxID
Clinically BAG is well functioning, stable, safe and well tolerated glass material that creates suitable local environment for permanent filling of frontal sinuses. Remnants of glass particles found in the bony filling seem to maintain the achieved bone formation and closure of sinuses. The healing process and stability of the clinical outcome in sinuses could be assessed reliably by using the ROI assessments.
In patients with orbital floor fractures the orbital floor prostheses manufactured from BAG have been well functioning and well tolerated. The same conclusion can be made on the use of BAG in septum perforations and narrowing of the nasal cavity. The material itself has not caused any harmful reactions during the clinical follow-up period.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vivoxid Ltd. % C.G. Bundy Associates, Inc. Ms. Constance G. Bundy 6470 Riverview Terrace Fridley, Minnesota 55432
OCT 1 9 2007
Re: K071937
Trade/Device Name: BonAlive™ Granules and BonAlive™ Plates Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: KKY Dated: October 1, 2007 Received: October 4, 2007
Dear Ms. Bundy:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
4
Page 2 - Ms. Constance G. Bundy
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obhain, other general information on your responsibilities under the Act from the Division of a mall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely your Mark N. Melkers
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Vivoxic
Indications for Use
510(k) Number (if known): K071937
Device Name: BonAlive™ Granules and BonAlive™ Plates
Indications for Use:
BonAlive™ Granules and BonAlive™ Plate are intended for the augmentation or reconstruction of the cranio-maxillofacial skeleton.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ ...... ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
11071937 510(k) Number
Vivoxid Ltd. Turku, Finland