(224 days)
Not Found
No
The summary describes a collagen-based bone filling material and makes no mention of AI or ML technology.
No
The device is described as a "bone filling augmentation material" and a "bone filler device" for filling extraction sockets, not for treating a disease or condition. Its purpose is structural augmentation, not therapy.
No
The device is described as a 'bone filling augmentation material' and a 'collagen plug' used for 'filling of extraction sockets', which indicates a therapeutic or reconstructive purpose, not a diagnostic one.
No
The device description clearly states it is a "collagen-based bone filling augmentation material" and a "sponge-like absorbable natural collagen plug," indicating it is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- FOUNDATION Device Function: The FOUNDATION device is a material used to fill extraction sockets in the body. It is a physical material implanted or placed within the body, not a test performed on a sample taken from the body.
The description clearly indicates it's a bone filling augmentation material for use in the body, not a diagnostic test performed on a sample from the body.
N/A
Intended Use / Indications for Use
The FOUNDATION device is a collagen-based bone filling augmentation material for use in filling of extraction sockets.
Product codes
LYC
Device Description
The FOUNDATION bone filler device is a sponge-like absorbable natural collagen plug designed to be used as indicated. FOUNDATION consists of approximately 85-95% Type I collagen and approximately 5-15% Type III collagen from bovine dermis.
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
Not Found
Key Metrics
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
KII1087
Section 5.0 510(k) Summary
NOV 2 9 2011
ッ
Property
| Submitter Name:
Submitter Address: | Olympus Terumo Biomaterials Corporation
Shinjuku Monolith
3-1 Nishi-Shinjuku 2-chome
Shinjuku-ku
Tokyo, Japan 163-0914 |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:
Telephone Number
for US Agent: | Laura Storms-Tyler, US Agent
484-896-5688 |
| Date Prepared: | August 25, 2011 |
| Device Trade Name: | FOUNDATION |
| Classification Name
and Number:
Class:
Product Code
Common Name: | Bone grafting material
21 CFR 872.3930
2
LYC
Bone grafting material, synthetic |
| Predicate Device: | FOUNDATION, Terumo Corporation, K040783 |
| Statement of
Intended Use: | The FOUNDATION device is a collagen-based bone filling
augmentation material for use in filling of extraction sockets. |
| Device Description,
Summary of
Technological
Characteristics | The FOUNDATION bone filler device is a sponge-like absorbable
natural collagen plug designed to be used as indicated.
FOUNDATION consists of approximately 85-95% Type I collagen
and approximately 5-15% Type III collagen from bovine dermis. |
| Comparison to the
Predicate Device | The FOUNDATION is available as a bullet shape in three sizes (in
mm: 8x15, 8x25, 15x25) and a sheet type in two sizes (mm: 25x25
and 50x25). The device is provided sterile, for single use in a heat-
sealed aluminum package. |
| | The FOUNDATION is substantially equivalent to its parent
FOUNDATION predicate device in the raw material source and
type of collagen, in device design, and in product forms and sizes: |
| Conclusion regarding
Substantial
Equivalence | The difference in the country source for the bovine raw material is
the purpose for submitting this 510(k). Appropriate controls and
validations assure there is no effect on the safety, performance,
and thus substantial equivalence of the new FOUNDATION
compared to the predicate. |
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Olympus Terumo Biomaterials Corporation C/O Ms. Patsy J. Trisler Regulatory Consultant Trisler Consulting 5600 Wisonsin Avenue, # 509 Chevy Chase, Maryland 20815
NOV 2 9 2011
Re: K111087
Trade/Device Name: Foundation Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: October 24, 2011 Received: October 27, 2011
Dear Ms. Trisler:
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. Trisler
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
h 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
510(k) Number (if known): Kil 1087
Device Name:
.
Foundation
Indications for Use:
The FOUNDATION device is a collagen-based bone filling augmentation material for use in filling of extraction sockets.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Susan Rumer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _KI | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |