(110 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device called TricOs T™ Resorbable Bone Substitute. The focus is on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and device performance through a detailed clinical study with numerical metrics. Therefore, many of the requested elements for describing such a study are not explicitly present in the provided document.
However, I can extract information related to the study conducted to support the expanded indication.
Here's the information derived from the provided text, addressing your questions to the best of its ability:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria (e.g., specific percentages, thresholds for bone growth, strength, etc.) or report numerical device performance metrics against such criteria. The "assessment of nonclinical data" section states that the device's performance has been addressed by comparative testing. The conclusion states the device "performs well" and is "as safe and effective as the predicate devices."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative criteria in the document. The overall implicit acceptance criterion is "substantial equivalence" to predicate devices for the expanded intended use. | "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 study. The results obtained from this study support the claim for substantial equivalence to BIO-OSS® devices for the new 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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. It mentions "a sinus lift animal model study."
- Data Provenance: The study was conducted on "a sinus lift animal model." No country of origin is specified. The study design appears to be prospective (pre-clinical testing for regulatory submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This was an animal model study, not a human reader study requiring expert interpretation of diagnostic images. The "ground truth" would likely be histological analysis of the animal tissue, performed by veterinary pathologists or similar specialists, but this is not detailed in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was an animal model study, not a human reader study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. The study described is an animal model study to demonstrate performance for a bone void filler.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone void filler, not an AI algorithm. The performance evaluation was of the physical device in an animal model.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth would likely be established through pathology (histological analysis) of the animal model tissue to assess bone ingrowth and resorption of the material, but this is not explicitly stated in the document.
8. The sample size for the training set
Not applicable. This is not an AI/ML device. The "training set" concept does not apply.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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:
| 5. 510(K) SUMMARY | |
|---|---|
| DATE: | March 10, 2008 APR - 8 2008 |
| OWNER: | Baxter Healthcare CorporationOne Deerfield ParkwayDeerfield, IL 60015 |
| CONTACT PERSON: | Barbara BarbeauSenior Director, Global Regulatory Affairs1620 Waukegan Road, MPGR-ALMcGaw Park, IL 60085Telephone: 847-473-6274Fax: 847-785-5116Email: Barbara_Barbeau@baxter.com |
| DEVICE NAME: | Proprietary Name: TricOs T' Resorbable BoneSubstituteCommon/Usual Name: Bone Void FillerClassification Name: Resorbable Calcium Salt BoneVoid FillerProduct Code: LYC |
| PREDICATE DEVICES: | TricOs T Resorbable Bone Substitute (K051722)Geistlich BIO-OSS®, BIO-OSS® Blocks and BIO-OSS® Collagen (K033815) |
| STATEMENT OFINTENDED USE: | TricOs T Resorbable Bone Substitute is indicated foruse as a bone void filler for voids and gaps that are notintrinsic to the stability of the bony structure. It isindicated for surgically created osseous defects orosseous defects resulting from traumatic injury.TricOs T Resorbable Bone Substitute is intended to fill,augment, or reconstruct bony defects of the oral andmaxillofacial region. Following placement in bonyvoids or gaps, TricOs T Resorbable Bone Substitute is |
I TricOs T is a trademark of Baxter Healthcare Corporation
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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
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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
§ 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.