(110 days)
Not Found
No
The summary describes a bone substitute material and its intended use, with no mention of AI or ML technology.
Yes
The device is a bone substitute intended to fill, augment, or reconstruct bony defects, indicating a therapeutic purpose in aiding the healing process.
No.
The device is a bone substitute used to fill bone voids and gaps, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it 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 describes the device as a bone void filler for surgical procedures to fill, augment, or reconstruct bony defects. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details the composition and function of the material as a scaffold and binder for bone growth. This aligns with a medical device used in surgery, not a diagnostic test performed on a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance study described is an animal model study evaluating the device's function as a bone void filler, not a study evaluating its diagnostic accuracy.
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
TricOs T 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 T 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 T Resorbable Bone Substitute is resorbed while providing support for the in-growth of bone during the healing process. TricOs T Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.
Product codes
LYC, NUN
Device Description
TricOs T 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; skeletal
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
Description of the test set: comparative testing in a sinus lift animal model study
Sample size: Not Found
Data source: Not Found
Annotation protocol: Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: comparative testing in a sinus lift animal model study
Sample size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results: The results obtained from this study support the claim for substantial equivalence to BIO-OSS® devices for the new intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
:
| 5. 510(K) SUMMARY | |
|---|---|
| DATE: | March 10, 2008 APR - 8 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: 847-473-6274 | |
| Fax: 847-785-5116 | |
| Email: Barbara_Barbeau@baxter.com | |
| DEVICE NAME: | Proprietary Name: TricOs T' Resorbable Bone |
| Substitute | |
| Common/Usual Name: Bone Void Filler | |
| Classification Name: Resorbable Calcium Salt Bone | |
| Void Filler | |
| Product Code: LYC | |
| PREDICATE DEVICES: | TricOs T Resorbable Bone Substitute (K051722) |
| Geistlich BIO-OSS®, BIO-OSS® Blocks and BIO- | |
| OSS® Collagen (K033815) | |
| STATEMENT OF | |
| INTENDED USE: | TricOs T 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 T 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 T Resorbable Bone Substitute is |
I TricOs T is a trademark of Baxter Healthcare Corporation
1
resorbed while providing support for the in-growth of bone during the healing process. TricOs T Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended. TricOs T Resorbable Bone Substitute consists of an DEVICE DESCRIPTION:
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.
TECHNOLOGICAL CHARACTERISTICS:
TricOs T 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) K051722 with regard to technological characteristics, performance, and components. The Baxter TricOs T Resorbable Bone Substitute is intended for oral and maxillofacial applications in the same capacity as the BIO-OSS®, BIO-OSS® Blocks and BIO-OSS® Collagen products (K033815).
ASSESSMENT OF NONCLINICAL DATA:
The intended use of the subject device is being expanded to include bone void filling for the oral and maxillofacial region of the skeleton. The subject and predicate TricOs T device materials 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 in the oral and maxillofacial region of the skeleton has been addressed by comparative testing in a sinus lift animal model
2
study. The results obtained from this study support the claim for substantial equivalence to BIO-OSS® devices for the new intended use.
CONCLUSIONS:
The proposed TricOs T 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 devices and the TricOs T Resorbable Bone Substitute performs well in skeletal and oral and maxillofacial region.
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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara K. Barbeau Sr. Director, Global Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road MP GR-AL McGaw Park, IL 60085
APR - 8 2008
Re: K073571
Trade/Device Name: TricOs T™ Resorbable Bone Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Codes: LYC and NUN Dated: March 31, 2008 Received: April 1, 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.
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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 (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.
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,
Snute Y. Michael Omd.
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
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4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K073571
Device Name:
TricOs T Resorbable Bone Substitute
Indication(s) for Use:
TricOs T 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 T 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 T Resorbable Bone Substitute is resorbed while providing support for the ingrowth of bone during the healing process. TricOs T Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.
| Prescription Use: | |
|---|---|
| 21 CFR 801 Subpart D | |
| Over-the-Counter Use: | |
| 21 CFR Subpart C |
Concurrence of CDRH, Office of Device Evaluation (ODE WADN
(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
1 TricOs T is a trademark of Baxter Healthcare Corporation
10(k) Number: Kr73571