(109 days)
Not Found
Not Found
No
The summary describes a resorbable calcium sulfate paste used as a barrier and does not mention any computational or analytical functions that would involve AI/ML.
No
The device acts as a barrier to prevent particle migration and is placed over bone graft materials; it does not directly treat a disease or condition.
No
Explanation: The device is described as a barrier over bone graft materials to prevent particle migration in an osseous defect. Its function is to create a physical barrier and set into a paste; it does not involve diagnosing any condition or disease.
No
The device description explicitly states it is a calcium sulfate powder and mixing diluent that forms a paste, indicating it 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 is to act as a barrier over bone graft materials in an osseous defect. This is a direct therapeutic or structural application within the body.
- Device Description: The device is a calcium sulfate powder and diluent that forms a paste and sets as a barrier. This describes a material used for physical support or containment within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are used in vitro (outside the body) to analyze samples like blood, urine, or tissue to provide diagnostic information. Fortoss-Cema™ is used in vivo (within the body) for a structural/barrier purpose.
N/A
Intended Use / Indications for Use
Fortoss-Cema™ is used as a barrier over bone graft materials to prevent particle migration in an osseous defect.
Fortoss-Cema™ is a resorbable pre-measured powder which, when blended with the supplied sterile diluent, forms a setting paste. Fortoss-Cema™ is indicated for use as a barrier in placement over bone graft material to prevent particle migration in an osseous defect.
Product codes
LYC
Device Description
Fortoss-Cema™ is a medical grade calcium sulfate powder and mixing diluent The blended materials form a creamy paste which set to form a barrier over bone graft materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Osseous defect
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Lifecore Biomedical CapSet™
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
JAN 1 4 2000
510(k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS
Fortoss-Cema™
In accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92 Biocomposites Ltd is hereby submitting the 510(k) Summary of Safety and Effectiveness for Fortoss-Cema™.
-
A. Submitter
Biocomposites Ltd Etruscan Street Etruria Stoke-on-Trent England ST1 5PQ -
B. Contact Person
J Stephen Bratt LL.B -
C. Date Prepared
22nd September 1999 -
D. Name of the Device
Fortoss-Cema™ -
E. Common or Usual Name
Calcium Sulfate Hemihydrate -
F. Classification Name
Implant, endosseous for bone filling and/or augmentation -
G. Predicate/Legally Marketed Devices
Lifecore Biomedical CapSet™
1
H. Device Description
Fortoss-Cema™ is a medical grade calcium sulfate powder and mixing diluent The blended materials form a creamy paste which set to form a barrier over bone graft materials.
I. Intended Use
Fortoss-Cema™ is used as a barrier over bone graft materials to prevent particle migration in an osseous defect.
Substantial Equivalence J.
Fortoss-Cema™ is substantially equivalent in design, function and intended use to the predicate device Lifecore Biomedical CapSet™.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2000
Mr. J.S. Bratt Manaqing Director Biocomposites, Ltd. Etruscan Street, Etruria, Stroke-on-Trent Staffordshire, ST1, 5PQ, England
Re: K993238
Fortoss Cema™ Calcium Sulfate Barrier Trade Name: Regulatory Class: Unclassified Product Code: LYC Dated: December 17, 1999 Received: December 20, 1999
Dear Mr. Bratt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Bratt
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K993238
Device Name:
Fortoss Cema™
Indications For Use:
Fortoss-Cema™ is a resorbable pre-measured powder which, when blended with the supplied sterile diluent, forms a setting paste.
Fortoss-Cema™ is indicated for use as a barrier in placement over bone graft material to r orcess only - barrier and prevent particle migration in an osseous defect.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use レ (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-
Susan Dunne
Division Sign-Off Division of Dental, Infection Control, and General Hospital Dev 510(k) Number