(308 days)
No
The description focuses on the material composition and physical properties of a bone void filler, with no mention of AI or ML capabilities.
Yes
ReproBone is described as a "bone void filler" that "acts as an osteoconductive scaffold" and "gradually resorbs and is replaced with bone during the healing process," indicating it is used to treat or manage a condition (bone defects) in the human body.
No
The device description clearly states "ReproBone® is a sterile, single-use, resorbable bone void filler" and its intended uses are for augmentation, reconstruction, and filling of bone defects, acting as an osteoconductive scaffold. These are therapeutic functions, not diagnostic ones.
No
The device description clearly states that ReproBone is a "sterile, single-use, resorbable bone void filler" made of calcium phosphate ceramic, which is a physical material, not software.
Based on the provided information, ReproBone is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of ReproBone is for augmentation and reconstructive treatment of bone defects in the body (specifically the alveolar ridge, sinus floor, etc.). This is a therapeutic and structural purpose, not for diagnosing a condition.
- Device Description: ReproBone is described as a sterile, single-use, resorbable bone void filler that acts as an osteoconductive scaffold. This description aligns with a medical device used for surgical procedures and tissue regeneration, not for in vitro testing of samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, ReproBone is a medical device used for surgical and regenerative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ReproBone 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), and filling of peri-implant defects in conjunction with products intended for guided bone regeneration (GBR).
Product codes
LYC
Device Description
ReproBone® is a sterile, single-use, resorbable bone void filler. ReproBone® is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate. ReproBone" has a highly interconnected, highly porous structure, similar to that of human cancellous bone, and is available in the form of granules of size range 0.5 - 1.0mm, and also 0.8-1.5mm. Following placement in the bony voids or gap, ReproBone® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. ReproBone® gradually resorbs and is replaced with bone during the healing process
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, infrabony periodontal, root resection, extraction sockets, maxillary sinus floor, peri-implant
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)
Non clinical performance data: Tests applied are those specified in ISO 13779-1 for hydroxyapatite which include chemical analysis, trace elements, chrystalline content and mechanical properties (compressive strength). In vivo (animal) and in vitro cell studies were carried out whereby compared to a predicate device. Reprobone was equivalent in terms of cell attachment and proliferation as well as bone formation and device reesorption.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bio-Oss® Granules (K033815), Bioactys® (K082286), MBCP® (K051885)
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
510(k) Summary
Ulsvis
NOV - 3 2011
ReproBone®
Preparation Date: 31st October 2011
1. Submitter's Information
| Company: | Ceramisys Ltd |
|---|---|
| Address: | Alison Business Centre |
| Alison Crescent | |
| Sheffield S2 1AS, England |
- 44 114 242 7630 Telephone: Facsimile: + 44 114 242 7631 Contact: Mr Wayne Austin (Managing Director)
2. Name of Device
| Trade Name: | ReproBone® |
|---|---|
| Common Name: | Resorbable calcium salt bone void filler device |
| Classification name: | Bone Grafting Material, Synthetic |
| Product Code: | LYC |
| Device panel: | Oral/Dental |
3. Legally Marketed Predicate'Device
The subject device is substantially equivalent to previously cleared devices. Bio-Oss® Granules (K033815) Bioactys® (K082286) MBCP® (K051885)
4. Device Description
ReproBone® is a sterile, single-use, resorbable bone void filler. ReproBone® is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate. ReproBone" has a highly interconnected, highly porous structure, similar to that of human cancellous bone, and is available in the form of granules of size range 0.5 - 1.0mm, and also 0.8-1.5mm. Following placement in the bony voids or gap, ReproBone® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. ReproBone® gradually resorbs and is replaced with bone during the healing process
5. Intended Use
ReproBone is recommended for augmentation or reconstructive treatment of the alveolar ridge, filling of infrabony periodontal defects, filling of defects after root resection apicoectorny 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), and filling of peri-implant defects in conjunction with products intended for guided bone regeneration (GBR).
1
6. Technological characteristics
ReproBone® and the predicate devices have the same technological characteristics, function and intended use. The Bioactys® predicate device (K082286) is constructed of the ratio 60% hydroxyapatite and 40% tricalcium phosphate which is identical to the composition of ReproBone®. All have a similar highly porous structure that promotes bone ingrowth by osteoconduction, and are gradually resorbable. ReproBone® and the predicate devices are provided sterile for single-use.
7. Non clinical performance data
Tests applied are those specified in ISO 13779-1 for hydroxyapatite which include chemical analysis, trace elements, chrystalline content and mechanical properties (compressive strength).
In vivo (animal) and in vitro cell studies were carried out whereby compared to a predicate device. Reprobone was equivalent in terms of cell attachment and proliferation as well as bone formation and device reesorption.
8. Conclusion
The safety and effectiveness and performance equivalence of ReproBone® resorbable bone graft substitute for use in dental and periodontal bone voids is adequately supported by the substantial equivalence information as well as comparative biocompatibility testing, and safety and performance data provided within this Premarket Notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 3 2011
Mr. Hillard W. Welch U.S. Representative for Ceramisys Limited Ceramisys Limited 344 Annabelle Point Road Centerville, Massachusetts 02632
Re: K103820
Trade/Device Name: ReproBone® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Il Product Code: LYC Dated: October 18, 2011 Received: October 20, 2011
Dear Mr. Welch:
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.
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Page 2 - Mr. Welch
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/CDRH0ffices/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,
Nh 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
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Indications for Use
510(k) Number (if known): K103820
Device Name: ReproBone
Indications for Use:
ReproBone 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 peri-implant defects in conjunction with products intended for guided bone regeneration (GBR).
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kummer
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K163820