(114 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 described as a bone void filler that provides "support for the in-growth of bone during the healing process" in surgically created osseous defects or those resulting from traumatic injury, which clearly indicates a therapeutic purpose.
No
The device is a bone void filler intended to support bone growth during healing, not to diagnose a condition.
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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description and intended use of TricOs A Resorbable Bone Substitute clearly state that it is a material intended to be implanted into the body to fill bone voids and support bone growth. It is a physical material used in vivo (within the living body).
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test. Its function is structural and biological support for bone healing.
Therefore, TricOs A Resorbable Bone Substitute falls under the category of an implantable medical device, not an In Vitro Diagnostic.
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 be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, pelvis). 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
MQV
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
Skeletal system (i.e., the extremities, spine, and pelvis)
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. The TricOs A Resorbable Bone Substitute is substantially equivalent to the predicate devices. Testing has been verified against established standards and guidelines for its intended use and demonstrates that the proposed device is as safe and effective for the intended use as the predicate devices.
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
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
and the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of the
OCT 1 . 2008
Page 1 of 3 Section 5, 510(k) Šummary
K 081 717
| 5. 510(K) SUMMARY |
|---|
| ------------------- |
| DATE: | June 16, 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 SubstituteCommon Name:Bone Void FillerClassification:Resorbable Calcium Salt Bone Void FillerClass:Class IIProduct Code:MQV | Trade Name: | Tricos A¹ Resorbable Bone Substitute | Common Name: | Bone Void Filler | Classification: | Resorbable Calcium Salt Bone Void Filler | Class: | Class II | Product Code: | MQV | |
| Trade Name: | Tricos A¹ Resorbable Bone Substitute | ||||||||||
| Common Name: | Bone Void Filler | ||||||||||
| Classification: | Resorbable Calcium Salt Bone Void Filler | ||||||||||
| Class: | Class II | ||||||||||
| Product Code: | MQV | ||||||||||
| 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 | |
| the oral and | ||
| maxillofacial region | April 8, 2008 |
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 TricOs A Resorbable Bone Substitute is indicated for INTENDED USE: 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 be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). 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 the skeletal system is substantially equivalent to Baxter's current legally marketed TricOs T Resorbable Bone Substitute cleared by 510(k) K051722 with regard to intended use. TricOs A Resorbable Bone Substitute for the skeletal system is substantially equivalent to TricOs T Resorbable Bone Substitute cleared by 510(k)s K051722 and K073571 with regard to technological characteristics and performance.
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.
CONCLUSIONS:
The TricOs A Resorbable Bone Substitute is substantially equivalent to the predicate devices. Testing has been verified against established standards and guidelines for its intended use and demonstrates that the proposed device is as safe and effective for the intended use as the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
OCT 1 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Baxter Healthcare Corporation % Ms. Valerie Followell Manager, Global Regulatory Affairs 1620 Waulkegan Road, MPGR-AL McGaw Park, Illinois 60085
Re: K081717
Trade/Device Name: TricOs A Resorbable Bone Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: October 06, 2008 Received: October 07, 2008
Dear Ms. Followell:
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, Or ug 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 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.
4
Page 2 – Ms. Valerie Followell
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
New special 510(k)
Device 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 be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, pelvis). 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.
| Prescription Use: | |
|---|---|
| 21 CFR 801 Subpart D | |
| Over-the-Counter Use: | |
| 21 CFR Subpart C |
Neil RP Onder for nxm
41-51-28
Concurrence of CDRH, Office of Device Evalualizes of
Division of General, Restorative, and Neurological Devices
1 TricOs A is a trademark of Baxter Healthcare Corporation
510(k) Number K081717