(332 days)
Not Found
No
The device description and intended use clearly define a bone graft substitute made of calcium phosphate ceramic. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is intended to fill, augment, or reconstruct periodontal or oral/maxillofacial defects and gradually resorb and be replaced by bone during the healing process, which directly addresses a medical condition or ailment.
No
Explanation: The device is a bone grafting material intended for filling, augmenting, or reconstructing defects. It is a therapy/treatment device, not a diagnostic one.
No
The device description clearly states it is a porous, resorbable, and biocompatible calcium phosphate ceramic in granular form, which is a physical material, not software.
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 the device is a bone grafting material used to fill, augment, or reconstruct defects in the body (periodontal or oral/maxillofacial). This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The description details the material composition (calcium phosphate ceramic) and form (granular) of the implant. This aligns with a medical device intended for implantation or direct application to tissue, not for testing samples outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Blue Sky Bio TCP Bone Graft Substitute is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
- Filling of periodontal/infrabony defects.
- Ridge augmentation.
- Filling of extraction sites (implant preparation/placement).
- Sinus lifts.
- Filling of cystic cavities.
The device gradually resorbs and is replaced with bone during the healing process.
Product codes
LYC
Device Description
Blue Sky Bio TCP Bone Graft Substitute is porous, resorbable, and biocompatible calcium phosphate ceramic consisting of ß-tricalcium phosphate. ß-tricalcium phosphate is an osteoconductive implant that is biodegradeable. Blue Sky Bio TCP Bone Graft Substitute is provided sterile in granular form, pyrogen-free and available in granule sizes up to 2000 μm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periodontal or oral/maxillofacial defects
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 following biocompatibility tests have been completed and results support that Blue Sky Bio TCP Bone Graft Substitute is compatible with surrounding tissues.
| Biocompatibility Tests | Results |
|---|---|
| Cytotoxicity | Pass |
| Intracutaneous Irritation Test | Pass |
| Maximization Sensitization Test | Pass |
| Pyrogen Test | Pass |
| Acute Toxicity | Pass |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 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 USA 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.
March 6, 2024
Blue Sky Bio, LLC Michele Vovolka Consultant 888 E Belvidere Rd. Suite 212 Grayslake, Illinois 60030
Re: K110198
Trade/Device Name: Blue Sky Bio TCP Bone Graft Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: Class II Product Code: LYC
Dear Michele Vovolka:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 22, 2011. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under the product code LYC.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Andrew Steen, OHT : Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6284, or andrew.steen@fda.hhs.gov.
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or other bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 2 2011
Ms. Vovolka Consultant Blue Sky Bio, LLC 888 E Belvidere Road, Suite 212 Grayslake, Illinois 60030
Re: K110198
Trade/Device Name: Blue Sky Bio TCP Bone Graft Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LPK Dated: December 12, 2011 Received: December 17, 2011
Dear Ms. Vovolka:
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.
2
Page 2 - Ms. Vovolka
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
hh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K110/98
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Blue Sky Bio TCP Bone Graft Substitute
Indications for Use: Blue Sky Bio TCP Bone Graft Substitute is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 . " · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · defects.
- Filling of periodontal/infrabony defects .
- Ridge augmentation .
- Filling of extraction sites (implant preparation/placement) .
- Sinus lifts .
- Filling of cystic cavities 0
The device gradually resorbs and is replaced with bone during the healing process.
Susan Russe
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110988
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
. . .
510(k) SUMMARY 5
OWNER:
Blue Sky Bio, LLC 888 E. Belvidere Suite 212 Grayslake, IL 60030 Telephone: 847-548-8499 Fax: 888-234-3685
OFFICIAL CONTACT:
Michele Vovolka Vantage Consulting International P.O. Box 848 Grayslake, IL 60030 Telephone: 815-856-0355 Fax: 888-234-3685 Email: vantagemv(0)comcast.net
DEVICE NAME:
Trade Name: Blue Sky Bio TCP Bone Graft Substitute Bone Grafting Material, for Dental Bone Repair Common Name: Bone Grafting Material Bone Grafting Material, Synthetic Classification Name: Class: Class II Regulation Number: 21 CFR 872.3930 LYC Product Code:
5
PREDICATE DEVICE(S):
| Predicate 510(k) | Device Name | Indication | Clearance Date | Company |
|---|---|---|---|---|
| K051443 | Cerasorb® M | |||
| Dental | Cerasorb® M DENTAL is recommended for: | |||
| • Augmentation or reconstructive treatment of the | ||||
| alveolar ridge | ||||
| • Filling of infrabony periodontal defects | ||||
| • Filling of defects after root resection, | ||||
| apicoectomy, and cystectomy | ||||
| • Filling of extraction sockets to enhance | ||||
| preservation of the alveolar ridge | ||||
| • Elevation of the maxillary sinus floor | ||||
| • Filling of periodontal defects in conjunction with | ||||
| products intended for Guided Tissue | ||||
| Regeneration (GTR) and Guided Bone | ||||
| Regeneration (GBR) | ||||
| • Filling of perio-implant defects in conjunction | ||||
| with products intended for Guided Bone | ||||
| Regeneration (GBR) | 22 July 2005 | Curasan AG, | ||
| Kleinostheim, | ||||
| Germany | ||||
| K083372 | ArrowBone-β | ArrowBone-β is intended for use in the | ||
| reconstruction of natural or surgical periodontal | ||||
| defects of the oral and maxillofacial region, | ||||
| including sinus floor elevation and augmentation of | ||||
| the alveolar crest. | ||||
| ArrowBone-β is intended for filling into the site of a | ||||
| bony defect in combination with patient blood, | ||||
| autologous bone, membranes or sterile saline after | ||||
| removal of cysts or surgical removal of retained | ||||
| tooth. | 8 December | |||
| 2009 | BrainBase | |||
| Corporation, | ||||
| Tokyo, Japan |
DEVICE DESCRIPTION:
Blue Sky Bio TCP Bone Graft Substitute is porous, resorbable, and biocompatible calcium phosphate ceramic consisting of ß-tricalcium phosphate. ß-tricalcium phosphate is an osteoconductive implant that is biodegradeable. Blue Sky Bio TCP Bone Graft Substitute is provided sterile in granular form, pyrogen-free and available in granule sizes up to 2000 μm.
6
STATEMENT OF INTENDED USE:
Blue Sky Bio TCP Bone Graft Substitute is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
- · Filling of periodontal/infrabony defects
- · Ridge augmentation
- · Filling of extraction sites (implant preparation/placement)
- Sinus lifts
- · Filling of cystic cavities
The device gradually resorbs and is replaced with bone during the healing process.
TECHNOLOGICAL CHARACTERISTICS:
The Blue Sky Bio TCP Bone Graft Substitute consists of pure ß-tricalcium phosphate as described in ASTM F1088-04, Standard Specification for ß-tricalcium Phosphate for Surgical Implants.
The following biocompatibility tests have been completed and results support that Blue Sky Bio TCP Bone Graft Substitute is compatible with surrounding tissues.
| Biocompatibility Tests | Results |
|---|---|
| Cytotoxicity | Pass |
| Intracutaneous Irritation Test | Pass |
| Maximization Sensitization Test | Pass |
| Pyrogen Test | Pass |
| Acute Toxicity | Pass |
7
BASIS FOR SUBSTANTIAL EQUIVALENCE:
Blue Sky Bio TCP Bone Graft Substitute meets the requirements of established standards for materials, biocompatibility, pyrogenicity and sterilization.
Blue Sky Bio TCP Bone Graft Substitute is substantially equivalent to the currently marketed Cerasorb® M DENTAL and BrainBase Corporation ArrowBone-B, as a bone void filler for defects in the oral/maxillary and dental region. These bone graft materials are equivalent in that they consist of ß-tricalcium phosphate with a phase purity of more than 95% and comply with ASTM F 1088-04. The devices are substantially equivalent with regard to materials as demonstrated by comparison of XRD profiles and dissolution testing, intended use, indications for use, anatomical site and performance data.
The information provided in this submission demonstrates that the Blue Sky Bio TCP Bone Graft Substitute is substantially equivalent to the predicate devices.