(168 days)
Not Found
No
The document describes a synthetic bone void filler material and its physical properties, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a bone void filler that resorbs and is replaced with bone during the healing process, and is indicated for use in the treatment of osseous defects, which directly addresses a disease or condition.
No
TRIHA+ is intended for use as a bone void filler to promote bone healing, not to diagnose medical conditions or diseases.
No
The device description clearly states that TRIHA+ is a physical implant made of synthetic beta tri calcium phosphate, intended for use as a bone void filler. It describes its material composition, structure, and how it resorbs and is replaced by bone. This is a hardware device, 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 TRIHA+ is a bone void filler for surgical and traumatic osseous defects. It is implanted directly into the body to aid in bone healing.
- Device Description: The description details a synthetic implant made of calcium phosphate with specific physical properties (porosity, pore size) designed for implantation and resorption within the skeletal system.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. TRIHA+ is a therapeutic device used to treat a physical defect within the body.
N/A
Intended Use / Indications for Use
TRIHA+ is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. TRIHA+ is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. TRIHA+ should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
TRIHA+ is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Product codes
MOV
Device Description
TRIHA+ is an osseo-conductive macroporous implant made of synthetic béta tri calcium phosphate (_–TCP (Ca(PO).)) indicated for bone void filler. It has a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. The porosity is 60-80% and the size of pores is 200-500μm. TRIHA+ implant slowly resorbs during the remodelling and bone defect repair process and is progressively replaced with bone. The progressive resorption of TRIHA+ is intended to prevent premature resorption.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skeletal system (i.e. 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
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)
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§ 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
Date November 21, 2003
Submitter Teknimed, S.A. 11 rue Apollo 31240 L'Union FRANCE
Contact person J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name Bone void filler
Classification name Filler, calcium sulfate, preformed pellets (per 21 CFR section 888.3045)
Equivalent Device
TRIHA+ is equivalent in material, indications and use as BIOSORB (K021763) (Sciences et Bio Materiaux, Lourdes, France) and Vitoss™ Scaffold (K994337) (Orthovita, Inc. (Malvern PA).
Device Description
TRIHA+ is an osseo-conductive macroporous implant made of synthetic béta tri calcium phosphate (_-TCP (Ca(PO).) indicated for bone void filler. It has a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. The porosity is 60-80% and the size of pores is 200-500μm. TRIHA+ implant slowly resorbs during the remodelling and bone defect repair process and is progressively replaced with bone. The progressive resorption of TRIHA+ is intended to prevent premature resorption.
Intended Use
TRIHA+ is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. TRIHA+ is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. TRIHA+ should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
TRIHA+ is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Summary of Technological Characteristics Compared to Predicate Device
TRIHA+ is similar to the predicate devices in terms of composition, porosity, pore size, and resorption.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a human head and torso.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 28 2003
Teknimed SA c/o Mr. J.D. Webb 1001 Oakwood Blvd. Round Rock, TX 78681 Attn. J.D. Webb
Re: K031826
Trade Name: TRIHA+ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: September 10, 2003 Received: September 16, 2003
Dear Mr. Webb:
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.
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
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Page 2 - Mr. J.D. Webb
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely vours,
for Mark A. Mullann
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) number (if known):
Device Name:
Indications for Use:
TRIHA+ Indications for Use
13 182
TRIHA+ is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. TRIHA+ is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. TRIHA+ should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
TRIHA+ is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of General, Neurological and Restorative Devices
510(k) Number ----------------------------------------------------------------------------------------------------------------------------------------------------------------
Prescription Use J (per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional format 1-2-96)
for Mark N. Millman
rision vision of General, Restorative and Neurological Devices
"(':) Number_