(49 days)
No
The summary describes a bone substitute material and its intended use, without any mention of AI or ML technology in its function, design, or performance evaluation.
Yes
The device is described as a "bone void filler" intended to "fill, augment, or reconstruct bony defects" and "provide support for the in-growth of bone during the healing process," which directly implies a therapeutic function.
No
Explanation: The document describes a bone substitute used to fill and augment bone defects, promoting bone growth. It does not mention any function related to identifying, analyzing, or determining a medical condition.
No
The device description clearly states that the device consists of an inorganic calcium phosphate scaffold and a heterologous human fibrin matrix, which are physical components, 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 TricOs A Resorbable Bone Substitute is a bone void filler for surgical and traumatic defects in the oral and maxillofacial region. It is used in vivo (within the body) to support bone growth.
- Device Description: The description details a calcium phosphate scaffold mixed with a fibrin matrix, designed for physical placement within a bone defect.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to test blood, urine, tissue samples, etc., to detect diseases, conditions, or markers. This device is a therapeutic implant used directly in the body.
N/A
Intended Use / Indications for Use
TricOs A Resorbable Bone Substitute is indicated for use as a bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs A Resorbable Bone Substitute is intended to fill, augment, or reconstruct bony defects of the oral and maxillofacial region. Following placement in bony voids or gaps, TricOs A Resorbable Bone Substitute is resorbed while providing support for the in-growth of bone during the healing process. TricOs A Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.
Product codes (comma separated list FDA assigned to the subject device)
LYC, NUN
Device Description
TricOs A Resorbable Bone Substitute consists of an inorganic calcium phosphate scaffold that is mixed with a heterologous human fibrin matrix prior to application. The fibrin matrix acts as a binder for the calcium phosphate scaffold, imparting favorable handling characteristics to the product to facilitate the surgical procedure, and acting as a three-dimensional matrix that supports the in-growth of bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral and maxillofacial region
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)
Baxter Heathcare conducted a risk assessment according to the requirements of ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices. The TricOs T and TricOs A device material and component specifications are similar. The device components continue to meet the same material testing standards and sterilization processing standards. Device performance as a bone void filler of the skeleton system has been verified in animal studies using a rabbit femoral condyles model and through functional and biocompatibility testing. Device performance as a bone void filler in the oral and maxillofacial region has been addressed by comparative testing in a sinus lift animal model study and through functional and biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
| 5. 510(K) SUMMARY | | |
12081721 | |
|--------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------|------------------------|--|
| DATE: | June 16, 2008 | | AUG - 6 2008 | |
| OWNER: | Baxter Healthcare Corporation | | | |
| | One Deerfield Parkway
Deerfield, IL 60015 | | | |
| CONTACT PERSON: | Barbara Barbeau | | | |
| | Senior Director, Global Regulatory Affairs | | | |
| | 1620 Waukegan Road, MPGR-AL | | | |
| | McGaw Park, IL 60085 | | | |
| | Telephone: 847-270-4174 | | | |
| | Fax: 847-785-5116 | | | |
| | Email: Barbara_Barbeau@baxter.com | | | |
| DEVICE NAME: | Trade Name: | Tricos A¹ Resorbable Bone
Substitute | | |
| | Common Name | Bone Void Filler | | |
| | Classification Name: | | Bone Grafting Material | |
| | Class: | Class II | | |
| | Product Code: | LYC, NUN | | |
| PREDICATE DEVICES: | Previously cleared 510(k)s for
Baxter Healthcare Corporation, Tricos T
Resorbable Bone Substitute product. | | | |
| | Previous 510(k) | Indication | Clearance Date | |
| | K051722 | Bone void filling of
the skeletal system | November 18, 2005 | |
| | K073571 | Bone void filling of | April 8, 2008 | |
the oral and
maxillofacial region
.
. .
1 TricOs A is a trademark of Baxter Healthcare Corporation
1
DEVICE DESCRIPTION:
TricOs A Resorbable Bone Substitute consists of an inorganic calcium phosphate scaffold that is mixed with a heterologous human fibrin matrix prior to application. The fibrin matrix acts as a binder for the calcium phosphate scaffold, imparting favorable handling characteristics to the product to facilitate the surgical procedure, and acting as a three-dimensional matrix that supports the in-growth of bone.
STATEMENT OF INTENDED USE:
TricOs A Resorbable Bone Substitute is indicated for use as a bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs A Resorbable Bone Substitute is intended to fill, augment, or reconstruct bony defects of the oral and maxillofacial region. Following placement in bony voids or gaps, TricOs A Resorbable Bone Substitute is resorbed while providing support for the in-growth of bone during the healing process. TricOs A Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.
TECHNOLOGICAL CHARACTERISTICS:
TricOs A Resorbable Bone Substitute for oral and maxillofacial region is substantially equivalent to Baxter's current legally marketed TricOs T Resorbable Bone Substitute cleared by 510(k) K073571 with regard to technological characteristics, performance, and intended use.
2
ASSESSMENT OF NONCLINICAL DATA:
Baxter Heathcare conducted a risk assessment according to the requirements of ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices. The TricOs T and TricOs A device material and component specifications are similar. The device components continue to meet the same material testing standards and sterilization processing standards. Device performance as a bone void filler of the skeleton system has been verified in animal studies using a rabbit femoral condyles model and through functional and biocompatibility testing. Device performance as a bone void filler in the oral and maxillofacial region has been addressed by comparative testing in a sinus lift animal model study and through functional and biocompatibility testing.
CONCLUSIONS:
The proposed TricOs A Resorbable Bone Substitute has been verified against established standards and guidelines for its intended use. Testing demonstrates that the proposed device is as safe and effective as the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara K. Barbeau Senior Director, Global Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road MP GR-AL McGaw Park, Illinois 60085
AUG - 6 2008
Re: K081721
Trade/Device Name: TricOs A"" Resorbable Bone Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Codes: LYC, NUN Dated: June 16, 2008 Received: June 18, 2008
Dear Ms. Barbeau:
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.
4
Page 2 - Ms. Barbeau
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Wamuel-Land, mr for //
ct
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
K081721 New special 510(k)
Devicc Name:
TricOs A Resorbable Bone Substitute
Indication(s) for Use:
TricOs A Resorbable Bone Substitute is indicated for use as a bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs A Resorbable Bone Substitute is intended to fill, augment, or reconstruct bony defects of the oral and maxillofacial region. Following placement in bony voids or gaps, TricOs A Resorbable Bone Substitute is resorbed while providing support for the ingrowth of bone during the healing process. TricOs A Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.
Susan Evans
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081721
| Prescription Use: ☑ | Over-the-Counter Use: ☐ |
|---|---|
| 21 CFR 801 Subpart D | 21 CFR Subpart C |
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 TricOs A is a trademark of Baxter Healthcare Corporation