(82 days)
CAPSET® Calcium Sulfate Bone Graft Plaster
Not Found
No
The device description and intended use describe a bone cement material and its components, with no mention of AI or ML technology.
Yes
The device is described as a "Bone Cement" for use over a filled defect and as a binder of bone graft particles, which indicates its use in treating or therapeutic procedures.
No
The device is a bone cement used to fill defects and bind bone graft particles, not to diagnose conditions or diseases.
No
The device description clearly states it is a bone cement packaged in syringes containing powder and liquid components, which are physical materials, 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 for dental applications, specifically as a barrier and binder for bone graft particles in a filled defect. This is a therapeutic and structural use, not a diagnostic one.
- Device Description: The device is a bone cement made of calcium sulfate and a liquid component. It is mixed and hardens to provide a physical barrier and bind graft material. This is a material used in vivo (within the body), not in vitro (outside the body) for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, tissue) or to provide information about a patient's health status or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
3i® Calcium Sulfate Bone Cement is used over a filled defect providing a stable barrier to graft material migration and is also indicated for use as a binder of bone graft particles. For use in dental applications only.
Product codes
LYC
Device Description
38 Calcium Sulfate Cement is packaged in two syringes. One svringe contains the powder component while the other syringe contains the liguid component. The powder component is calcium sulfate dihydrate (CaSO4 · 2H2O). The liquid component is a solution comprised of potassium citrate monohydrate (KaC6HsOr " H2O), sodium phosphate dibasic (NazHPO4 7H2O), and distilled water (H2O). The svringe with the liguid component comes with a female-female Luer coupler for connecting the two syringes together for mixing. When mixed, the powder and liquid combine to form a homogenous paste. The paste hardens approximately 5-10 minutes after the start of mixing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-Clinical Testing: 38 Calcium Sulfate Cement is biodegradable and in animal studies, depending on the defect size, was found to resorb in approximately four to eight weeks. Biocompatibilty testing and animal studies demonstrate the safety of the material, which was found to be non-toxic, non-mutagenic, non-hemolytic, and nonpyrogenic. Clinical Testing: Not performed on this device,
Key Metrics
Not Found
Predicate Device(s)
CAPSET® Calcium Sulfate Bone Graft Plaster
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
SEP 1 9 2001
KOIZ
Summary of Safety and Effectiveness
Applicant/Sponsor: Biomet, Inc. 56 E. Bell Drive Warsaw, Indiana 46582
- Contact Person: Mary L. Verstynen Telephone: (219) 267-6639 Fax: (219) 372-1683
Proprietary Name: 3i® Calcium Sulfate Bone Cement
Common Name: calcium sulfate dihydrate
Classification Name: Implant, endosseous for bone filling and/or reconstruction (872.3640)
Legally Marketed Device To Which Substantial Equivalence Is Claimed: CAPSET® Calcium Sulfate Bone Graft Plaster
Device Description: 318 Calcium Sulfate Cement is packaged in two syringes. One svringe contains the powder component while the other syringe contains the liguid component. The powder component is calcium sulfate dihydrate (CaSO4 · 2H2O). The liquid component is a solution comprised of potassium citrate monohydrate (KaC6HsOr " H2O), sodium phosphate dibasic (NazHPO4 7H2O), and distilled water (H2O). The svringe with the liguid component comes with a female-female Luer coupler for connecting the two syringes together for mixing. When mixed, the powder and liquid combine to form a homogenous paste. The paste hardens approximately 5-10 minutes after the start of mixing.
Intended Use: 3i® Calcium Sulfate Bone Cement is used over a filled defect providing a stable barrier to graft material migration and is also indicated for use as a binder of bone graft particles.
Summary of Technologies: The cement has the same technological characteristics as the predicate device
Non-Clinical Testing: 38 Calcium Sulfate Cement is biodegradable and in animal studies, depending on the defect size, was found to resorb in approximately four to eight weeks. Biocompatibilty testing and animal studies demonstrate the safety of the material, which was found to be non-toxic, non-mutagenic, non-hemolytic, and nonpyrogenic.
Clinical Testing: Not performed on this device,
00259
3i is a registered trademark of Implants Innovations, Inc. Capset is a registered trademark of Lifecore Biomedical, Inc.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure in profile, with three overlapping silhouettes suggesting a sense of community or interconnectedness.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2001
Implant Innovations, Incorporated C/O Ms. Mary L. Verstynen Biomet. Incorporated 56 East Bell Drive Warsaw, India 46582
Re: K012047
Trade/Device Name: 31 Calcium Sulfate Bone Cement Regulation Number: None Regulation Name: Calcium Ulfate Dihydrate Regulatory Class: Unclassified Product Code: LYC Dated: June 22, 2001 Received: June 29, 2001
Dear Ms. Verstynen:
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
2
Page 2 - Ms. Verstynen
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 er read on the quality systems (QS) regulation (21 CFR Part 820); and if roquirelier as as betronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.
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 premilated 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours,
L. Alatorre
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page of
510(k) NUMBER (IF KNOWN): ___K012047
DEVICE NAME: 3i® Calcium Sulfate Bone Cement
INDICATIONS FOR USE:
3i® 's Calcium Sulfate Bone Cement is used over a filled defect providing a stable barrier to graft material migration and is also indicated for use as a binder of bone graft particles.
For use in dental applications only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
Susan Pharr
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ COLORY